A Trial of PF-07901800 (TTI-621) for Patients With Hemato... | NCT02663518 | Trialant
NCT02663518
Sponsor
Pfizer
Status
Terminated
Last Update Posted
May 10, 2024Actual
Enrollment
249Actual
Phase
Phase 1
Conditions
Hematologic Malignancies
Solid Tumor
Interventions
PF-0791800 (TTI-621)
PF-07901800 (TTI-621) plus Rituximab
PF-07901800 (TTI-621) plus Nivolumab
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02663518
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TTI-621-01
Secondary IDs
ID
Type
Description
Link
C4961001
Other Identifier
Alias Study Number
Brief Title
A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
Official Title
A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Pfizer decided terminating study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.
Expanded Access Info
No
Start Date
Jan 28, 2016Actual
Primary Completion Date
Nov 23, 2022Actual
Completion Date
Nov 23, 2022Actual
First Submitted Date
Jan 19, 2016
First Submission Date that Met QC Criteria
Jan 25, 2016
First Posted Date
Jan 26, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 20, 2023
Results First Submitted that Met QC Criteria
Nov 20, 2023
Results First Posted Date
May 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 20, 2023
Last Update Posted Date
May 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
Detailed Description
This is a trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
TTI-621 (SIRPαFc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (anti phagocytic) signal to macrophages.
This trial will be conducted in 2 phases and 4 parts: Phase 1a Part 1 (escalation phase) and Phase 1b Parts 2-4 (expansion phase).
In the dose Escalation Phase (phase 1a Part 1), subjects with lymphoma will be enrolled in sequential dose cohorts to receive TTI-621 to characterize safety, tolerability, pharmacokinetics, and the maximum-tolerated dose (MTD).
In the Expansion Phase (phase 1b Parts 2-4), TTI-621 will be given to subjects with a variety of hematologic malignancies and selected solid tumors to further define safety and to characterize efficacy. In the Expansion Phase Part 2, the safety and efficacy of TTI-621 will also be assessed when it is given in combination with other anti-cancer drugs. The dose of TTI-621 to be delivered in the Expansion Phase Parts 2-3 of the study may be increased or decreased based on the subject's tolerability and on the subject's response to treatment.
In the phase 1b dose optimization of the study (Part 4), further dose escalation of TTI-621, beyond the dose determined during phase 1a dose escalation, will be pursued in patients with relapsed and/or refractory CTCL following a 3+3 escalation design and using a revised DLT criteria to further evaluate the safety and tolerability of TTI-621 at dose levels higher than the initially recommended phase 1b Parts 2-3.
Secondary objectives include further characterization of the pharmacokinetics, pharmacodynamics, and development of ADA; and to gain preliminary evidence of the anti-tumor activity of TTI-621 in subjects with a variety of hematologic malignancies and selected solid tumors. In addition, the safety of TTI-621 will be evaluated in combination with other anti-cancer agents.
Pfizer decided terminating this study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.
The Escalation Phase will include multiple doses of PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Indolent B-Cell Lymphoma
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Aggressive B-Cell Lymphoma
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
T-Cell Lymphoma
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Hodgkin Lymphoma
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Chronic Lymphocytic Leukemia
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-0791800 (TTI-621)
Drug
Monotherapy
Acute Myeloid Leukemia
Aggressive B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Cutaneous T-Cell Lymphoma (CTCL)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (<) 1.0 * 10^9/L. fever greater than (>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
Part 1: Day 1 of dosing up to Pre-dose on Day 22
Part 2 and 3: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Maximum Plasma Concentration (Cmax) of TTI-621
Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Phase 1b Expansion (Part 2 and 3) • Advanced malignancy: IBCL, ABCL, cHL, AML, ALL, MDS, MPN, SCLC, PTCL and CTCL; measurable disease who have relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporeal photochemotherapy (ECP) considered a systemic therapy. Local radiation and topical agents are not systemic therapies.
Phase 1b dose optimization (Part 4)
• Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome): Failed at least 2 prior systemic therapies for CTCL (Systemic therapy does not include local radiation therapy or topical agents); History of histologically documented diagnosis of CTCL stage IB to IVB
Inclusion Criteria (all subjects):
Advanced measurable malignancy with previously progressed on, or currently progressing on standard anticancer therapy or for whom no other approved conventional therapy exists
Eastern Cooperative Oncology Group (ECOG) 0-2
Adequate hematologic, hepatic, renal, and coagulation function; fresh or archived tumor tissue available for immunohistochemistry
Recovery from prior treatments and/or surgeries; no history of hemolytic anemia or bleeding diathesis.
AML M3 (French American British, FAB, classification) (i.e., acute promyelocytic leukemia [APL]) excluded
Exclusion Criteria:
Known current central nervous system disease involvement or untreated brain metastases
Allogeneic transplant within 30 days prior to the planned start of treatment or subjects with active graft-vs-host disease with the exception of Grade 1 skin involvement
Marks JA, Wang X, Fenu EM, Bagg A, Lai C. TP53 in AML and MDS: The new (old) kid on the block. Blood Rev. 2023 Jul;60:101055. doi: 10.1016/j.blre.2023.101055. Epub 2023 Feb 14.
Ansell SM, Maris MB, Lesokhin AM, Chen RW, Flinn IW, Sawas A, Minden MD, Villa D, Percival MM, Advani AS, Foran JM, Horwitz SM, Mei MG, Zain J, Savage KJ, Querfeld C, Akilov OE, Johnson LDS, Catalano T, Petrova PS, Uger RA, Sievers EL, Milea A, Roberge K, Shou Y, O'Connor OA. Phase I Study of the CD47 Blocker TTI-621 in Patients with Relapsed or Refractory Hematologic Malignancies. Clin Cancer Res. 2021 Apr 15;27(8):2190-2199. doi: 10.1158/1078-0432.CCR-20-3706. Epub 2021 Jan 15.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 249 participants were enrolled in the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG001
Periods
Title
Milestones
Reasons Not Completed
Part 1: Phase 1a Escalation
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 20, 2019
Nov 20, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
CD47
SIRPα-IgG1 Fc
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1a/1b trial of PF-07901800 (TTI-621) for relapsed or refractory hematologic malignancies and selected solid tumors were conducted in 4 parts. In the dose escalation phase (Part 1), advanced lymphomas were enrolled in sequential dose cohorts for safety, tolerability, PK, and MTD. In the expansion phase (Part 2), subjects with various hematologic malignancies and selected solid tumors were treated at recommended dose determined in phase 1a (Part 1) for safety and efficacy. In the expansion phase (Part 3), 2 cohorts (cutaneous T-cell lymphoma and peripheral T-cell lymphoma) were evaluated for potentially further studied using Simon 2-stage design. In the phase 1b dose optimization (Part 4), further dose escalation was investigated in patients with relapsed and/or refractory CTCL following a 3+3 escalation and revised DLT criteria.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Open label
Who Masked
Not provided
Drug: PF-0791800 (TTI-621)
Multiple Myeloma
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Acute Myeloid Leukemia
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Myelodysplastic Syndrome
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Myeloproliferative Neoplasms
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Small Cell Lung Cancer
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Rituximab Combination
Experimental
Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Rituximab for CD20 positive malignancies
Drug: PF-07901800 (TTI-621) plus Rituximab
Nivolumab Combination
Experimental
Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Nivolumab for Hodgkin Lymphoma
Drug: PF-07901800 (TTI-621) plus Nivolumab
Cutaneous T-Cell Lymphoma (CTCL)
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Peripheral T-Cell Lymphoma (PTCL)
Experimental
Monotherapy expansion cohort with PF-07901800 (TTI-621)
Drug: PF-0791800 (TTI-621)
Part 4: Cutaneous T-Cell Lymphoma (CTCL)
Experimental
Monotherapy expansion Part 4 (Dose Optimization) cohort with PF-07901800 (TTI-621)
Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
Part 4: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days)
Part 4: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration (ANC < 1.0 x 109/L, fever > 38.5°C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
Part 4: Day 1 of dosing up to Pre-dose on Day 22
Part 1: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells .
Part 1: Week 1 end of infusion (EOI)
Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had >1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a > [4-fold dilution increase] in titer from baseline in >1 post-treatment sample (treatment-boosted).
Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days)
Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621
Results for this outcome measure was reported for Part 2 and Part 3 combined.
Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
Results for this outcome measure was reported for Part 2 and Part 3 combined.
Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Part 2 and 3 Combined: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells. Results are reported for combined Part 2 and 3.
Part 2 and 3: Week 1 end of infusion (EOI)
Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had >1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a > 4-fold dilution increase in titer from baseline in > 1 post-treatment sample (treatment-boosted).
Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Part 2: Overall Response Rate (ORR)-Savona 2015- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Part 2: Overall Response Rate (ORR)- Durie 2006- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006). was used for assessment of tumors.Tumor types evaluated include Multiple Myeloma (MM).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Part 2: Overall Response Rate (ORR)- Bohnsack 2014- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had irComplete Response, IrPartial Response. Immune-Related Response Criteria: RECIST (Bohnsack et al., 2014) was used for assessment of tumor. Tumor types evaluated included Small Cell Lung Cancer (SCLC).
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Parts 2 and 3: Duration of Response (DoR)- Disease Indication and Nivolumab/Rituximab Combinations
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Parts 2 and 3: Progression Free Survival (PFS)
PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
Part 4: Maximum Plasma Concentration (Cmax) of TTI-621
Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Part 4: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells.
Part 4: Week 1 end of infusion (EOI)
Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had >1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a > [4-fold dilution increase] in titer from baseline in > 1 post-treatment sample (treatment-boosted).
Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)
Part 4: Overall Response Rate (ORR)
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, partial response. Lymphomas evaluated include Non-Hodgkin's Lymphoma. Clinical endpoints and response criteria in mycosis fungoides and Sezary syndrome (Olsen et al., 2011).
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
Part 4: Duration of Response (DoR)
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
Part 4: Overall Response Rate (ORR) in Cutaneous T-Cell Lymphoma (CTCL) Both Fungoides and Sezary Syndrome
ORR is presented in this outcome measure as number of responders.
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
Duarte
California
91010
United States
Freidenrich Center for Translational Research (CTRU)
Palo Alto
California
94304
United States
Stanford Cancer Institute
Palo Alto
California
94304
United States
Colorado Blood Cancer Institute
Denver
Colorado
80218
United States
Presbyterian/St.Luke's Medical Center
Denver
Colorado
80218
United States
Mayo Clinic Jacksonville
Jacksonville
Florida
32224
United States
Mayo Clinic
Jacksonville
Florida
32224
United States
Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa
Florida
33612
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Covance Biorepository
Greenfield
Indiana
46140
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Hackensack Meridian Health John Theurer Cancer Center
Hackensack
New Jersey
07601
United States
Hackensack UMC
Hackensack
New Jersey
07601
United States
The John Theurer Cancer Center at Hackensack UMC
Hackensack
New Jersey
07601
United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown
New Jersey
07748
United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison
New York
10604
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York
New York
10016
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
New York
10016
United States
NYU Investigational Pharmacy
New York
New York
10016
United States
NYU Langone Health (Tisch Hospital)
New York
New York
10016
United States
Memorial Sloan Kettering Cancer Center-Clinical Trails Office
New York
New York
10017
United States
Columbia Univeristy
New York
New York
10019
United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York
New York
10021
United States
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York
New York
10022
United States
Columbia University Medical Center.
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Cleveland Clinic Taussig Cancer Center
Cleveland
Ohio
44195
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Oregon Health & Science University-Research Pharmacy Services
Portland
Oregon
97239
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Oregon Health and Sciences University
Portland
Oregon
97239
United States
University of Pittsburgh Medical Center Presbyterian Shadyside
Pittsburgh
Pennsylvania
15213
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15237
United States
Centennial Medical Center
Nashville
Tennessee
37203
United States
Sarah Cannon Research Institute (Pharmacy)
Nashville
Tennessee
37203
United States
Tennessee Oncology PLLC
Nashville
Tennessee
37203
United States
Tennessee Oncology, PLLC
Nashville
Tennessee
37203
United States
Tennessee Oncology
Nashville
Tennessee
37203
United States
Myriad RMB Inc
Austin
Texas
78759
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
University of Texas MD Anderson Cancer Center, Cancer Prevention Center
Houston
Texas
77030
United States
University of Texas MD Anderson Cancer Center, Melanoma and Skin Clinic
Houston
Texas
77030
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
University of Washington - Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
Fairmont Medical Building, Suite 810
Vancouver
B.C.
V5Z1H7
Canada
British Columbia Cancer Agency
Vancouver
British Columbia
V5Z 1H6
Canada
Princess Margaret Cancer Center
Toronto
Ontario
M5G 2M9
Canada
University Health Network - Princess Margaret Cancer Centre
Johnson LDS, Banerjee S, Kruglov O, Viller NN, Horwitz SM, Lesokhin A, Zain J, Querfeld C, Chen R, Okada C, Sawas A, O'Connor OA, Sievers EL, Shou Y, Uger RA, Wong M, Akilov OE. Targeting CD47 in Sezary syndrome with SIRPalphaFc. Blood Adv. 2019 Apr 9;3(7):1145-1153. doi: 10.1182/bloodadvances.2018030577.
Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG002
Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG003
Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG004
Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 2
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Participants with Classical Hodgkin's Lymphoma (cHL) received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 milligram per meter square (mg/m^2) rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
FG007
Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 3
Participants with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG008
Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG009
Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG010
Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG011
Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG012
Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG013
Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
FG0003 subjectsPart 1 participants.
FG0013 subjectsPart 1 participants.
FG0027 subjectsPart 1 participants.
FG0035 subjectsPart 1 participants.
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0027 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Progressive Disease
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG004
Informed Consent Withdrawn
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Part 2 and 3: Phase 1b Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNo participants for part 2 and 3.
FG0010 subjectsNo participants for part 2 and 3.
FG0020 subjectsNo participants for part 2 and 3.
FG0030 subjectsNo participants for part 2 and 3.
FG004107 subjectsPart 2 participants.
FG00511 subjectsPart 2 participants.
FG00640 subjectsPart 2 participants.
FG00742 subjectsPart 3 participants.
FG0080 subjectsNo participants for part 2 and 3.
FG0090 subjectsNo participants for part 2 and 3.
FG0100 subjectsNo participants for part 2 and 3.
FG0110 subjectsNo participants for part 2 and 3.
FG0120 subjectsNo participants for part 2 and 3.
FG0130 subjectsNo participants for part 2 and 3.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 4: Phase 1b Dose Optimization
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNo participants for part 4.
FG0010 subjectsNo participants for part 4.
FG0020 subjectsNo participants for part 4.
FG0030 subjectsNo participants for part 4.
FG0040 subjectsNo participants for part 4.
FG0050 subjectsNo participants for part 4.
FG0060 subjectsNo participants for part 4.
FG0070 subjectsNo participants for part 4.
FG0083 subjectsPart 4 participants.
FG0093 subjectsPart 4 participants.
FG0106 subjectsPart 4 participants.
FG0113 subjectsPart 4 participants.
FG01212 subjectsPart 4 participants.
FG0134 subjectsPart 4 participants.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Analysis population included all the participants who received at least one dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG004
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG005
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
BG006
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
BG007
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG008
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG009
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG010
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG011
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG012
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG013
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0027
BG0035
BG004107
BG00511
BG00640
BG00742
BG0083
BG0093
BG0106
BG0113
BG01212
BG0134
BG014249
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
< 65 Years
BG0002
BG0013
BG0026
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Safety population included all the participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)
ID
Title
Description
OG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0027
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0003
OG0013
OG0027
OG003
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (<) 1.0 * 10^9/L. fever greater than (>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, or participants who experienced an AE, meeting DLT criteria during that time. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Part 1: Day 1 of dosing up to Pre-dose on Day 22
ID
Title
Description
OG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Primary
Part 2 and 3: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Analysis population included all the participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
ID
Title
Description
OG000
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Primary
Part 4: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Analysis population included all the participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days)
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Primary
Part 4: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration (ANC < 1.0 x 109/L, fever > 38.5°C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, OR participants who experienced an AE, meeting DLT criteria during that time. As 2.0mg/kg Q2W cohort was not a part of escalation for dose optimization, and not relevant to DLT assessment hence this outcome measure was not analyzed for Q2W arm. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Part 4: Day 1 of dosing up to Pre-dose on Day 22
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 1: Maximum Plasma Concentration (Cmax) of TTI-621
Pharmacokinetic (PK)-evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
ID
Title
Description
OG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
PK evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram*hour/milliliter
Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
ID
Title
Description
OG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 1: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells .
This outcome measure was not analyzed since CD47 data for Part 1 was not collected as the assay was not set up when enrolling the Part 1 participants. Hence, no participants evaluable for this outcome measure.
Posted
Part 1: Week 1 end of infusion (EOI)
ID
Title
Description
OG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had >1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a > [4-fold dilution increase] in titer from baseline in >1 post-treatment sample (treatment-boosted).
Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.
Posted
Count of Participants
Participants
Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days)
ID
Title
Description
OG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621
Results for this outcome measure was reported for Part 2 and Part 3 combined.
PK evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
ID
Title
Description
OG000
Part 2 and 3 Combined: 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 2 and 3 Combined: 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 2 and 3 Combined: 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
Results for this outcome measure was reported for Part 2 and Part 3 combined.
PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure. Data for only those arms [according to dose] are reported for this outcome measure which had any evaluable participants.
Posted
Mean
Standard Deviation
Nanogram*hour per milliliter
Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
ID
Title
Description
OG000
Part 2 and 3 Combined: 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 2 and 3 Combined: 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 2 and 3 Combined: 0.3 mg/kg
Secondary
Part 2 and 3 Combined: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells. Results are reported for combined Part 2 and 3.
Safety population included all the participants who received at least one dose of study treatment. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure.
Posted
Mean
Standard Deviation
Percentage of Cells
Part 2 and 3: Week 1 end of infusion (EOI)
ID
Title
Description
OG000
Part 2 and 3 Combined: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 2 and 3 Combined: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Secondary
Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had >1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a > 4-fold dilution increase in titer from baseline in > 1 post-treatment sample (treatment-boosted).
Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.
Posted
Count of Participants
Participants
Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
ID
Title
Description
OG000
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Secondary
Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Aggressive B-cell Lymphoma (ABCL)
Participants with ABCL who received study drug in Part 2.
OG001
Part 2: Hodgkin Lymphoma (HL)
Participants with HL who received study drug in Part 2.
Secondary
Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3.
OG001
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Olsen 2011 in Parts 2 and 3.
Units
Counts
Participants
Secondary
Part 2: Overall Response Rate (ORR)-Savona 2015- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Myelodysplastic Syndrome (MDS)
Participants with MDS who received study drug in part 2.
OG001
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in part 2.
Units
Counts
Participants
Secondary
Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Chronic Lymphocytic Leukemia (CLL)
Participants with CLL who received study drug in part 2.
Units
Counts
Participants
OG000
Secondary
Part 2: Overall Response Rate (ORR)- Durie 2006- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006). was used for assessment of tumors.Tumor types evaluated include Multiple Myeloma (MM).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Multiple Myeloma (MM)
Participants with MM who received study drug in part 2.
Units
Counts
Participants
OG000
Secondary
Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Acute Myeloid Leukemia (AML)
Participants with AML who received study drug in part 2.
Units
Counts
Participants
OG000
Secondary
Part 2: Overall Response Rate (ORR)- Bohnsack 2014- Disease Indication
ORR is presented in this outcome measure as number of responders. Responders were those who had irComplete Response, IrPartial Response. Immune-Related Response Criteria: RECIST (Bohnsack et al., 2014) was used for assessment of tumor. Tumor types evaluated included Small Cell Lung Cancer (SCLC).
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2.
Units
Counts
Participants
OG000
Secondary
Parts 2 and 3: Duration of Response (DoR)- Disease Indication and Nivolumab/Rituximab Combinations
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Aggressive B-cell Lymphoma (ABCL)
Participants with ABCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG001
Part 2: Acute Myeloid Leukemia (AML)
Participants with AML who received study drug in Part 2. Response included morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment.
Secondary
Parts 2 and 3: Progression Free Survival (PFS)
PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 2: Aggressive B-cell Lymphoma (ABCL)
Participants with ABCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG001
Part 2: Acute Myeloid Leukemia (AML)
Participants with AML who received study drug in Part 2. Response included morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment.
Secondary
Part 4: Maximum Plasma Concentration (Cmax) of TTI-621
The Pharmacokinetic (PK)-evaluable Set consists of treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram*hour per milliliter
Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 4: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells
CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells.
Safety population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percentage of cells
Part 4: Week 1 end of infusion (EOI)
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had >1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a > [4-fold dilution increase] in titer from baseline in > 1 post-treatment sample (treatment-boosted).
Immunogenicity analysis population includes all treated participants with at least one (ADA) Anti-Drug Antibody sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 4: Overall Response Rate (ORR)
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, partial response. Lymphomas evaluated include Non-Hodgkin's Lymphoma. Clinical endpoints and response criteria in mycosis fungoides and Sezary syndrome (Olsen et al., 2011).
Analysis population included all the participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Secondary
Part 4: Duration of Response (DoR)
DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.
Analysis population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Secondary
Part 4: Overall Response Rate (ORR) in Cutaneous T-Cell Lymphoma (CTCL) Both Fungoides and Sezary Syndrome
ORR is presented in this outcome measure as number of responders.
Data for this outcome measure is not available as analysis was not performed because: 1) due to futility and heterogenicity of respective data of the parameters of organ system (i.e., skin, blood, lymph node, and viscera; 2) the Olsen 2011 criteria already defined the "Global Response Score" to determine the Global Response (GR) consisting of the 4 components which (GR) was more important assessment affecting overall prognosis.
Posted
From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)
ID
Title
Description
OG000
Part 4: CTCL
Participants with CTCL who received study drug in part 4.
Units
Counts
Participants
OG000
Time Frame
Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Description
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
0
3
1
3
2
3
EG001
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
1
3
0
3
3
3
EG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
1
7
1
7
7
7
EG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
1
5
2
5
5
5
EG004
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
52
107
43
107
100
107
EG005
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
0
11
2
11
11
11
EG006
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
27
40
13
40
34
40
EG007
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
16
42
15
42
36
42
EG008
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
0
3
1
3
3
3
EG009
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
0
3
1
3
2
3
EG010
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
2
6
2
6
6
6
EG011
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
0
3
0
3
3
3
EG012
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
5
12
3
12
12
12
EG013
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
1
4
3
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sepsis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG0030 affected5 at risk
EG0044 affected107 at risk
EG0050 affected11 at risk
EG0061 affected40 at risk
EG0073 affected42 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected6 at risk
EG0110 affected3 at risk
EG0120 affected12 at risk
EG0130 affected4 at risk
Pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pneumonia Fungal
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Abdominal Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Bronchitis Viral
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Campylobacter Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cytomegalovirus Infection Reactivation
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hepatic Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pelvic Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pneumococcal Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pneumonia Aspiration
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Septic Shock
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Skin Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Staphylococcal Bacteraemia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Staphylococcal Sepsis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Haemolytic Uraemic Syndrome
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Thrombotic Thrombocytopenic Purpura
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Depressed Level Of Consciousness
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Seizure
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cardio-Respiratory Arrest
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Death
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Painful Respiration
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Acute Erythroid Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Acute Myeloid Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Cutaneous T-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Malignant Pleural Effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Myelodysplastic Syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Major Depression
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Graft Versus Host Disease
Immune system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Haemophagocytic Lymphohistiocytosis
Immune system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Influenza A Virus Test Positive
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Dermatitis Exfoliative Generalised
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Intramedullary Rod Insertion
Surgical and medical procedures
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0024 affected7 at risk
EG0032 affected5 at risk
EG00439 affected107 at risk
EG0050 affected11 at risk
EG00618 affected40 at risk
EG00713 affected42 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0101 affected6 at risk
EG0110 affected3 at risk
EG0124 affected12 at risk
EG0130 affected4 at risk
Chills
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Oedema Peripheral
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0024 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0024 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected7 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected7 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0023 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected7 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected7 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected7 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0025
OG0035
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0032
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
OG003
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Units
Counts
Participants
OG000107
OG00142
OG00211
OG00340
Title
Denominators
Categories
TEAEs
Title
Measurements
OG000103
OG00140
OG00211
OG00337
TESAEs
Title
Measurements
OG00043
OG00115
OG0022
OG003
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: TTI-621 2 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG00412
OG0054
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0003
OG0013
OG0026
OG0033
OG00412
OG0054
TESAEs
Title
Measurements
OG0001
OG0011
OG0022
OG003
OG001
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: TTI-621 2 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG0047
OG0050
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0027
OG0035
Title
Denominators
Categories
Title
Measurements
OG000136.594± 64.248
OG001366.636± 67.433
OG002823.137± 153.681
OG0031579.799± 518.546
OG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0001
OG0012
OG0025
OG0034
Title
Denominators
Categories
Title
Measurements
OG0001200.722
OG0016178.488± 844.463
OG00218873.939± 6213.503
OG00336782.700± 8700.626
OG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG002
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0027
OG0034
Title
Denominators
Categories
ADA Positive: Overall Incidence
Title
Measurements
OG0001
OG0010
OG0021
OG0030
NAb Positive: Overall Incidence
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Part 2 and 3 Combined: 0.4 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 2 and 3 Combined: 0.5 mg/kg
Participants with advanced relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG00050
OG001147
OG0020
OG0031
OG0040
Title
Denominators
Categories
Title
Measurements
OG000341± 160
OG0011020± 1270
OG003673
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 2 and 3 Combined: 0.4 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 2 and 3 Combined: 0.5 mg/kg
Participants with advanced relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG00036
OG001133
OG0020
OG0031
OG0040
Title
Denominators
Categories
Title
Measurements
OG0009330± 10300
OG00120000± 10400
OG00316100
Participants
OG00033
OG001113
Title
Denominators
Categories
Title
Measurements
OG00024.99± 16.54
OG00131.39± 17.28
OG002
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
OG003
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG00094
OG00111
OG00236
OG00337
Title
Denominators
Categories
ADA Positive: Overall Incidence
Title
Measurements
OG00014
OG0010
OG0021
OG0035
NAb Positive: Overall Incidence
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
Part 2: Indolent B-cell Lymphoma (IBCL)
Participants with IBCL who received study drug in Part 2.
OG003
Part 2: Classical Hodgkin's Lymphoma (cHL)
Participants with cHL who received nivolumab combination in Part 2.
OG004
Part 2: CD20-positive Malignancies
Participants with CD20-positive malignancies who received rituximab combination in Part 2.
OG005
Parts 2 and 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Parts 2 and 3.
OG006
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
Units
Counts
Participants
OG0005
OG00113
OG0025
OG00311
OG00440
OG00521
OG00611
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0034
OG0049
OG0053
OG0063
OG00021
OG00129
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0006
OG0013
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
3
Title
Denominators
Categories
Title
Measurements
OG0000
8
Title
Denominators
Categories
Title
Measurements
OG0000
20
Title
Denominators
Categories
Title
Measurements
OG0002
4
Title
Denominators
Categories
Title
Measurements
OG0000
OG002
Part 2: Chronic Lymphocytic Leukemia (CLL)
Participants with CLL who received study drug in Part 2. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment.
OG003
Part 2: Hodgkin Lymphoma (HL)
Participants with HL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG004
Part 2: Indolent B-cell Lymphoma (IBCL)
Participants with IBCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG005
Part 2: Myelodysplastic Syndrome (MDS)
Participants with MDS who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
OG006
Part 2: Multiple Myeloma (MM)
Participants with MM who received study drug in Part 2. Response included complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006) was used for assessment.
OG007
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
OG008
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
OG009
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG010
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
OG011
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
OG012
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
OG013
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0084
OG0093
OG0109
OG0110
OG0122
OG0138
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI could not be estimated due to less number of participants with events.
OG001NA(NA to NA)Median and 95% CI could not be estimated due to less number of participants with events.
OG0078.3(NA to NA)95% CI could not be estimated due to less number of participants with events.
OG0089.2(NA to NA)95% CI could not be estimated due to less number of participants with events.
OG00912.0(NA to NA)95% CI could not be estimated due to less number of participants with events.
OG0103.1(1.9 to 21.3)
OG0121.9(1.8 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0138.3(1.0 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG002
Part 2: Chronic Lymphocytic Leukemia (CLL)
Participants with CLL who received study drug in Part 2. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines Chronic lymphocytic leukemia (CLL) Participants with (CLL) NOTE: An Arm/Group Description is shorter than the Arm/Group Title. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment.
OG003
Part 2: Hodgkin Lymphoma (HL)
Participants with HL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG004
Part 2: Indolent B-cell Lymphoma (IBCL)
Participants with IBCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG005
Part 2: Myelodysplastic Syndrome (MDS)
Participants with MDS who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
OG006
Part 2: Multiple Myeloma (MM)
Participants with MM who received study drug in Part 2. Response included complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006) was used for assessment.
OG007
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
OG008
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
OG009
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
OG010
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
OG011
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
OG012
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
OG013
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
Units
Counts
Participants
OG0003
OG00117
OG0022
OG0039
OG0043
OG0055
OG0068
OG0072
OG0085
OG00914
OG01037
OG0110
OG0129
OG01322
Title
Denominators
Categories
Title
Measurements
OG0001.6(0.7 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0010.8(0.7 to 1.0)
OG0021.4(0.8 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0033.1(1.0 to 4.4)
OG0041.4(0.7 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0050.8(0.7 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0061.1(0.7 to 1.3)
OG00711.0(5.6 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0083.5(0.7 to NA)Upper limit of 95% CI could not be estimated due to less number of participants with events.
OG0091.7(1.5 to 3.1)
OG0101.7(1.5 to 2.3)
OG0125.4(1.9 to 10.8)
OG0132.6(1.6 to 15.8)
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0025
OG0032
OG00410
OG0051
Title
Denominators
Categories
Title
Measurements
OG0004040± 110
OG0016190± 1100
OG00210000± 4400
OG00315400± 2470
OG00423600± 4530
OG00518800
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0025
OG0032
OG0048
OG0050
Title
Denominators
Categories
Title
Measurements
OG00088800± 12300
OG001116000± 38800
OG002212000± 85700
OG003383000± 49600
OG004638000± 120000
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0045
OG0053
Title
Denominators
Categories
Title
Measurements
OG00062.25± 12.65
OG00165.49± 24.80
OG00237.17± 32.93
OG00357.09± 23.72
OG00465.00± 5.97
OG00549.51± 10.83
OG002
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG00411
OG0054
Title
Denominators
Categories
ADA Positive: Overall Incidence
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
NAb Positive: Overall Incidence
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG00412
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0042
OG0050
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG003
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG004
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
OG005
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0031
OG0042
OG0050
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)Median and 95% CI could not be estimated due to less number of participants with events.
OG003NA(NA to NA)Median and 95% CI could not be estimated due to less number of participants with events.
OG004NA(NA to NA)Median and 95% CI could not be estimated due to less number of participants with events.