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The purpose of this study is to learn about the safety and what the body does to the medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple myeloma.
Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies).
This study is seeking participants who:
All participants in this study will receive Maplirpacept as an intravenous (IV) infusion (given directly into a vein) at the study clinic every week.
Participants will continue to receive Maplirpacept until:
The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine Maplirpacept, is safe and can be given to Chinese people.
The study is composed of 2 parts. In Part A, approximately 3-6 participants are expected to be enrolled to confirm the tolerability in Chinese participants. If deemed safe, the enrollment of Part B will proceed to include a total of approximately 9 participants in the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy of single agent PF-07901801 (Maplirpacept).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maplirpacept (PF-07901801) | Experimental | single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maplirpacept | Drug | Study drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept. | Cycle 1:up to 21 days |
| Single-dose Cmax | Maximum Observed Plasma Concentration | 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8 |
| Single-dose AUClast | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8 |
| Single-dose AUCtau | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week. | 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. Relatedness to study drug was assessed by the investigator. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Guangdong Provincial People's Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Baseline up to 28 days after the last dose of study drug |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing | Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion. | Baseline up to 28 days after the last dose of study drug |
| Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration) | Pharmacokinetics of Maplirpacept | 0, 1, 2, 4, 24, 72 hours post-dose up to Day8 |
| Multiple-dose Cmax (Maximum Observed Plasma Concentration) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Multiple-dose Ctrough (trough concentration) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Multiple-dose Rac (Accumulation Ratio) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| CL (Systemic Clearance) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Vss (Volume of Distribution at Steady State) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| t½ (Plasma Decay Half-Life) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time) | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Incidence and titers of anti-drug antibodies against TTI-622 | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Incidence and titers of neutralizing antibodies against TTI-622 | Pharmacokinetics of Maplirpacept | Through study completion, up to 18 months |
| Objective Response | To assess the preliminary antitumor activity of Maplirpacept | Baseline to measured progressive disease, up to 18 months |
| Time to Tumor Response (TTR) | To assess the preliminary antitumor activity of Maplirpacept | Baseline to measured progressive disease, up to 18 months |
| Duration of Response (DOR) | To assess the preliminary antitumor activity of Maplirpacept | Baseline to measured progressive disease, up to 18 months |
| Progression-Free Survival (PFS) | To assess the preliminary antitumor activity of Maplirpacept | Baseline to measured progressive disease, up to 18 months |
| Minimal Residual Disease (MRD) | To assess the preliminary antitumor activity of Maplirpacept. Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria. | Baseline to measured progressive disease, up to 18 months |
| Guangzhou |
| Guangdong |
| 510080 |
| China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |