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| ID | Type | Description | Link |
|---|---|---|---|
| C4971002 | Other Identifier | Alias Study Number |
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A business decision was made by Pfizer to terminate and remove the Phase 2 expansion of this study for administrative reasons. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
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Pegylated liposomal doxorubicin (PLD), a type of chemotherapy, is a standard treatment option for patients with platinum-resistant ovarian cancer. However, despite being consider a standard treatment option, the clinical benefit of chemotherapy alone for these patients is small. Historically, response rates for PLD monotherapy have only ranged from 12 to 35% with a high likelihood of recurrence within months after treatment initiation. Although bevacizumab (BEV), an anti-new-vascular growth monoclonal antibody has been approved by FDA to combine with standard chemotherapy (e.g., PLD) for platinum-resistant recurrent ovarian cancer, there are still many restrictions or contraindications preventing certain women from receiving bevacizumab's combination treatment. The goal of this study is to improve upon the activity of PLD in a safe manner to provide a more effective therapeutic option for this group of patients.
The purpose of this study is to assess maplirpacept (PF-07901801) administered in combination with PLD in patients with platinum-resistant ovarian cancer and for whom PLD is a reasonable treatment option. The first portion of the study will evaluate the safety of increasing dose levels of maplirpacept (PF-07901801) in combination with PLD at 40 mg/m2 in patients with platinum-resistant EOC (epithelial ovarian cancer). This is a group of cancer, including ovarian, peritoneal, and fallopian tube malignancy. The aim of the first portion of the study is to establish a combination regimen for further assessment in a dose expansion cohort.
The study will consist of a 28-day screening period to ensure participants are qualified for the study treatment plan. During the treatment period, patients will receive maplirpacept (PF-07901801) in combination with PLD in 28-day cycles until their disease progresses or unacceptable toxicity develops. There will be a long-term follow-up period in this study to assess overall survival (length of time since start of treatment patients are alive).
Pegylated liposomal doxorubicin (PLD) is a standard treatment option for patients with platinum-resistant ovarian cancer who are not candidates for chemotherapy in combination with bevacizumab. However, despite being consider a standard treatment option, the clinical benefit of chemotherapy for this patient population is small. The goal of this clinical trial is to improve upon the activity of PLD in a safe manner to provide a more effective therapeutic option for this group of patients.
C4971002 (TTI-622-02) is a multi-center, open-label study designed to evaluate maplirpacept (PF-07901801) administered in combination with PLD in patients with platinum-resistant ovarian cancer and for whom PLD is a reasonable treatment option. The first portion of the study will evaluate the safety of increasing dose levels of maplirpacept (PF-07901801) in combination with PLD at 40 mg/m2 in patients with platinum-resistant EOC, including ovarian, peritoneal and fallopian tube malignancy, and establish a combination regimen for further evaluation in a dose expansion cohort. The study will consist of a 28-day screening period, a treatment period in which patients will receive maplirpacept (PF-07901801) in combination with PLD in 28-day cycles until documentation of objective disease progression or development of unacceptable toxicity, and a long-term follow-up period to assess overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Dose Escalation | Experimental | In the Phase 1 (dose escalation): Cycle 1 for dose levels 1 and 2, maplirpacept (PF-07901801) will be administered on Day 1, Day 8, Day 15 and Day 22 in combination with PLD on Day 1 of 28-day cycle. Beginning with Cycle 2 at dose levels 1 and 2, maplirpacept (PF-07901801) will be administered on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. For Phase 1, dose level 3, maplirpacept (PF-07901801) will be administered on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. Dose level 3 will be biweekly regimen from the start. |
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| Phase 2: Dose Expansion | Experimental | In the Phase 2 (dose expansion): maplirpacept (PF-07901801) will be administered with selected dose from the escalation phase by intravenous infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 in subsequent cycles in combination with Pegylated Liposomal Doxorubicin 40 mg/m2 by intravenous infusion on Day 1 of each 28-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maplirpacept (PF-07901801) | Drug | PF-07901801 Escalation (3-dose-level 12, 24, and 48 mg/kg), in combination with Pegylated Liposomal Doxorubicin (40mg/m2) will be administered by intravenous infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as hematologic and/or non-hematologic treatment-emergent adverse event (TEAE) that occurred during the 28-day Cycle 1 and were judged by the investigator as related to Maplirpacept or the combination of Maplirpacept and PLD. Adverse events (AEs) that were in the opinion of the investigator attributable exclusively to intravenous infusion of PLD or any PLD prophylaxis medication were not considered a DLT. | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With TEAEs, Serious TEAEs, >=3 Grade TEAEs, Treatment Related TEAEs, Treatment Related Serious TEAEs and >=3 Grade Treatment Related TEAEs | AE: untoward medical occurrence or the worsening of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to study treatment. TEAEs: event that occurred or worsened on or after start of Maplirpacept up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy; includes serious and all non-serious AEs. Serious AE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. AEs' severity graded using common terminology criteria for AEs (CTCAE) v 5.0; grade 3= severe; grade 4= life-threatening; grade 5= death. Treatment-related AE: untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to drug was assessed by investigator. |
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Key Inclusion Criteria:
or declined treatment with platinum-based chemotherapy.
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 |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Research Center | Santa Monica | California | 90403 | United States | ||
| Baptist Hospital of Miami |
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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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A total of 10 participants were enrolled and treated in the study (Phase 1).
There were 2 phases of the study: Phase 1 and 2. Due to business decision the study was terminated, and Phase 2 was not conducted. Hence, results in all sections are reported only for Phase 1 of the study and not for Phase 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Maplirpacept (PF-07901801) 12 mg/kg + Pegylated Liposomal Doxorubicin (PLD) | Participants received Maplirpacept 12 milligram per kilogram (mg/kg) by intravenous (IV) infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 milligram per meter square (mg/m^2) intravenously on Day 1 of each 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2022 | Oct 7, 2024 |
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Phase 1/2 (dose escalation and dose expansion)
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| Pegylated Liposomal Doxorubicin (PLD) | Drug | RP2D of maplirpacept (PF-07901801) biweekly of maplirpacept (PF-07901801) from Phase 1 escalation in combination with pegylated liposomal doxorubicin 40mg/m2 |
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| From start of treatment up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy whichever occurred first (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks) |
| Phase 1: Change From Baseline in Diastolic and Systolic Blood Pressure (BP) at End of Treatment | BP was measured in millimeter of mercury (mmHg). | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
| Phase 1: Change From Baseline in Respiratory Rate at End of Treatment | Respiratory rate was measured in breaths per minute (breaths/ min). | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
| Phase 1: Change From Baseline in Pulse Rate at End of Treatment | Pulse rate was measured in beats per minute (beats/min). | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
| Phase 1: Change From Baseline in Temperature at End of Treatment | Temperature was measured in degree Celsius (C). | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
| Phase 1: Change From Baseline in Weight at End of Treatment | Weight was measured in kilogram (kg). | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
| Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Standard 12-lead ECGs utilizing limb leads were used to interpret normal and abnormal results, QT interval. ECG was performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinical significance of ECG abnormalities were determined by the investigator. | During study treatment, (maximum up to 32 weeks) |
| Phase 1: Phase 1: Number of Participants With Shift to Grade 3/4 in Serum Chemistry Parameters Abnormalities From Baseline to Post-baseline During the Study Treatment | Serum chemistry tests included determination of the following parameters: glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate, blood urea nitrogen or urea, creatinine, total protein, albumin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, indirect bilirubin, uric acid, calcium, magnesium, and lactate dehydrogenase (LDH). The serum chemistry parameters were graded using CTCAE version 5.0. The intensity was assigned a grade of 1-5 using the following CTCAE guidelines: grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death. In this outcome measure number of participants with at least 1 event of shift to grade 3 or 4 in serum chemistry parameters abnormalities from baseline to post-baseline during study treatment are reported. | Baseline to post-baseline during study treatment (maximum up to 32 weeks) |
| Phase 1: Number of Participants With Shift to Grade 3/4 in Hematology Parameters Abnormalities From Baseline to Post-baseline During the Study Treatment | Hematology tests included determination of the following parameters: hemoglobin, hematocrit, platelets, white blood cells (WBC), neutrophils, lymphocytes, eosinophils, basophils, monocytes, WBC with automated 5-part differential, red blood cells (RBC), absolute reticulocytes, reticulocytes percentage (%), erythrocyte mean corpuscular hemoglobin (MCH), erythrocyte mean corpuscular volume (MCV), and red cell distribution width (RDW). Clinical significance was determined by the investigator. The hematology parameter was graded using CTCAE version 5.0. The intensity was assigned a grade of 1-5 using the following CTCAE guidelines: grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death. In this outcome measure number of participants with at least 1 event of shift to grade 3 or 4 in hematology parameters abnormalities from baseline to post-baseline during study treatment are reported. | Baseline to post-baseline during study treatment (maximum up to 32 weeks) |
| Phase 1: Number of Participants With Dose Delay | Dose delay was the difference between the actual time between two consecutive non-zero doses and the planned time between the same two consecutive non-zero doses. In this outcome measure number of participants with any event of dose delay are reported. | During study treatment, (maximum up to 32 weeks) |
| Phase 1: Number of Participants Who Discontinued Study Treatment Due to TEAE | In this outcome measure number of participants who discontinued study treatment due to TEAE are reported. TEAEs: event that occurred or worsened on or after start of Maplirpacept up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy; includes serious and all non-serious AEs. | During study treatment, (maximum up to 32 weeks) |
| Phase 1: Progression Free Survival (PFS), Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | PFS: time from the first Maplirpacept infusion (Cycle 1 Day 1) to disease progression (PD) or death of any cause, whichever occurred first. Participants who completed or discontinued the study without PD or death, as well as participants who received alternate anti-cancer therapy prior to PD, were censored at their last adequate response assessment date or last adequate assessment prior to the start date of alternate anti-cancer therapy. If date of progression occurred on the same date as the start of new anticancer therapy, the progression was counted as an event. PD per RECIST v1.1: at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of 1 or more new lesions. Analysis was performed using Kaplan-Meier method. | From first Maplirpacept infusion till PD or death or censoring date, whichever occurred earlier (maximum up to 32 weeks) |
| Phase 1: Overall Survival (OS) | OS was defined as the time from the first Maplirpacept infusion (Cycle 1 Day 1) to death of any cause. Participants without death date at the time of analysis were censored at their last known alive date. Analysis was planned to be performed using Kaplan-Meier method. However, the study was terminated prior to achieving meaningful number of events, hence Kaplan-Meier analysis was not conducted. In this outcome measure number of days from first Maplirpacept infusion until death for each participant (who had death as an event) is reported individually. | From first Maplirpacept infusion till death or censoring date, whichever occurred earlier (maximum up to 32 weeks) |
| Phase 1: Phase 1: Disease Control Rate (DCR), Per RECIST v1.1 | DCR: percentage of participants who had achieved complete response (CR), partial response (PR), or stable disease (SD) lasting at least 12 weeks. According to RECIST v1.1 criteria: CR = disappearance of all target lesions, any pathological lymph nodes (whether target or on-target) must have reduction in short axis to <10 mm; PR = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions. | From first Maplirpacept infusion till PD or death or censoring date, whichever occurred earlier (maximum up to 32 weeks) |
| Phase 1: Duration of Response (DOR) | DOR: for participants who achieved a confirmed CR or PR; defined as time from the date of first documented response (CR or PR) to the date of documented progression or death of any cause after achieving response. Participants who completed or discontinued the study without PD or death, as well as participants who received alternate anti-cancer therapy prior to PD, was censored at their last adequate response assessment date or last adequate assessment prior to start date of alternate anti-cancer therapy. CR=disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to <10 mm; PR=at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD= at least 20% increase in the sum of LD of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions. | From time of first documented CR or PR to progression or death or censoring date, whichever occurred earlier (maximum up to 32 weeks |
| Miami |
| Florida |
| 33176 |
| United States |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Orlando Health Cancer Institute Gynecologic Cancer Center | Orlando | Florida | 32806 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Michigan Healthcare Professionals PC | Dearborn | Michigan | 48126 | United States |
| Michigan Healthcare Professionals PC | Farmington Hills | Michigan | 48334 | United States |
| Michigan Healthcare Professionals PC | Royal Oak | Michigan | 48073 | United States |
| Michigan Healthcare Professionals PC | Sterling Heights | Michigan | 48314 | United States |
| Cleveland Clinic taussig Cancer Center Investigational Pharmacy | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Cleveland Clinic Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Oklahoma Cancer Specialist and Research Institute. LLC | Tulsa | Oklahoma | 74146 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Hillman Cancer Center-Investigational Drug Services | Pittsburgh | Pennsylvania | 15232 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| oncology Consultants, P.A. | Houston | Texas | 77024 | United States |
| FG001 | Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD | Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| FG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set (SAS) included all participants who received at least one dose of Maplirpacept.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Maplirpacept (PF-07901801) 12 mg/kg + PLD | Participants received Maplirpacept 12 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 IV on Day 1 of each 28-day cycle. |
| BG001 | Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD | Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| BG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as hematologic and/or non-hematologic treatment-emergent adverse event (TEAE) that occurred during the 28-day Cycle 1 and were judged by the investigator as related to Maplirpacept or the combination of Maplirpacept and PLD. Adverse events (AEs) that were in the opinion of the investigator attributable exclusively to intravenous infusion of PLD or any PLD prophylaxis medication were not considered a DLT. | DLT evaluation population set included all participants in Phase 1 who either experienced DLT after at least one dose of Maplirpacept or did not experience a DLT and received the full dose of PLD and at least two infusions of Maplirpacept and completed safety evaluations during the 28-day Cycle 1 DLT period. | Posted | Count of Participants | Participants | Cycle 1 (28 days) |
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| Secondary | Phase 1: Number of Participants With TEAEs, Serious TEAEs, >=3 Grade TEAEs, Treatment Related TEAEs, Treatment Related Serious TEAEs and >=3 Grade Treatment Related TEAEs | AE: untoward medical occurrence or the worsening of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to study treatment. TEAEs: event that occurred or worsened on or after start of Maplirpacept up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy; includes serious and all non-serious AEs. Serious AE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. AEs' severity graded using common terminology criteria for AEs (CTCAE) v 5.0; grade 3= severe; grade 4= life-threatening; grade 5= death. Treatment-related AE: untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to drug was assessed by investigator. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Count of Participants | Participants | From start of treatment up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy whichever occurred first (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks) |
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| Secondary | Phase 1: Change From Baseline in Diastolic and Systolic Blood Pressure (BP) at End of Treatment | BP was measured in millimeter of mercury (mmHg). | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Mean | Standard Deviation | mmHg | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
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| Secondary | Phase 1: Change From Baseline in Respiratory Rate at End of Treatment | Respiratory rate was measured in breaths per minute (breaths/ min). | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Mean | Standard Deviation | Breaths/ min | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
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| Secondary | Phase 1: Change From Baseline in Pulse Rate at End of Treatment | Pulse rate was measured in beats per minute (beats/min). | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Mean | Standard Deviation | Beats/ min | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
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| Secondary | Phase 1: Change From Baseline in Temperature at End of Treatment | Temperature was measured in degree Celsius (C). | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Mean | Standard Deviation | Degree C | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
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| Secondary | Phase 1: Change From Baseline in Weight at End of Treatment | Weight was measured in kilogram (kg). | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Mean | Standard Deviation | kg | Baseline (prior to the start of study treatment on Day 1 Cycle 1), End of treatment (maximum up to 32 weeks) |
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| Secondary | Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Standard 12-lead ECGs utilizing limb leads were used to interpret normal and abnormal results, QT interval. ECG was performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinical significance of ECG abnormalities were determined by the investigator. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Count of Participants | Participants | During study treatment, (maximum up to 32 weeks) |
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| Secondary | Phase 1: Phase 1: Number of Participants With Shift to Grade 3/4 in Serum Chemistry Parameters Abnormalities From Baseline to Post-baseline During the Study Treatment | Serum chemistry tests included determination of the following parameters: glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate, blood urea nitrogen or urea, creatinine, total protein, albumin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, indirect bilirubin, uric acid, calcium, magnesium, and lactate dehydrogenase (LDH). The serum chemistry parameters were graded using CTCAE version 5.0. The intensity was assigned a grade of 1-5 using the following CTCAE guidelines: grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death. In this outcome measure number of participants with at least 1 event of shift to grade 3 or 4 in serum chemistry parameters abnormalities from baseline to post-baseline during study treatment are reported. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Count of Participants | Participants | Baseline to post-baseline during study treatment (maximum up to 32 weeks) |
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| Secondary | Phase 1: Number of Participants With Shift to Grade 3/4 in Hematology Parameters Abnormalities From Baseline to Post-baseline During the Study Treatment | Hematology tests included determination of the following parameters: hemoglobin, hematocrit, platelets, white blood cells (WBC), neutrophils, lymphocytes, eosinophils, basophils, monocytes, WBC with automated 5-part differential, red blood cells (RBC), absolute reticulocytes, reticulocytes percentage (%), erythrocyte mean corpuscular hemoglobin (MCH), erythrocyte mean corpuscular volume (MCV), and red cell distribution width (RDW). Clinical significance was determined by the investigator. The hematology parameter was graded using CTCAE version 5.0. The intensity was assigned a grade of 1-5 using the following CTCAE guidelines: grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death. In this outcome measure number of participants with at least 1 event of shift to grade 3 or 4 in hematology parameters abnormalities from baseline to post-baseline during study treatment are reported. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Count of Participants | Participants | Baseline to post-baseline during study treatment (maximum up to 32 weeks) |
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| Secondary | Phase 1: Number of Participants With Dose Delay | Dose delay was the difference between the actual time between two consecutive non-zero doses and the planned time between the same two consecutive non-zero doses. In this outcome measure number of participants with any event of dose delay are reported. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Count of Participants | Participants | During study treatment, (maximum up to 32 weeks) |
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| Secondary | Phase 1: Number of Participants Who Discontinued Study Treatment Due to TEAE | In this outcome measure number of participants who discontinued study treatment due to TEAE are reported. TEAEs: event that occurred or worsened on or after start of Maplirpacept up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy; includes serious and all non-serious AEs. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Count of Participants | Participants | During study treatment, (maximum up to 32 weeks) |
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| Secondary | Phase 1: Progression Free Survival (PFS), Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | PFS: time from the first Maplirpacept infusion (Cycle 1 Day 1) to disease progression (PD) or death of any cause, whichever occurred first. Participants who completed or discontinued the study without PD or death, as well as participants who received alternate anti-cancer therapy prior to PD, were censored at their last adequate response assessment date or last adequate assessment prior to the start date of alternate anti-cancer therapy. If date of progression occurred on the same date as the start of new anticancer therapy, the progression was counted as an event. PD per RECIST v1.1: at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of 1 or more new lesions. Analysis was performed using Kaplan-Meier method. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Median | 95% Confidence Interval | Months | From first Maplirpacept infusion till PD or death or censoring date, whichever occurred earlier (maximum up to 32 weeks) |
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| Secondary | Phase 1: Overall Survival (OS) | OS was defined as the time from the first Maplirpacept infusion (Cycle 1 Day 1) to death of any cause. Participants without death date at the time of analysis were censored at their last known alive date. Analysis was planned to be performed using Kaplan-Meier method. However, the study was terminated prior to achieving meaningful number of events, hence Kaplan-Meier analysis was not conducted. In this outcome measure number of days from first Maplirpacept infusion until death for each participant (who had death as an event) is reported individually. | SAS included all participants who received at least one dose of Maplirpacept. "Number of Participants Analyzed" signifies participants with death as an event [0= no participant with event] and "Number Analyzed" signifies participants evaluable for specified rows. Since there were insufficient participants with event, data could not be summarized as planned by Kaplan-Meier analysis and have been reported for each participant who had event in applicable reporting arms. | Posted | Number | Days | From first Maplirpacept infusion till death or censoring date, whichever occurred earlier (maximum up to 32 weeks) |
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| Secondary | Phase 1: Phase 1: Disease Control Rate (DCR), Per RECIST v1.1 | DCR: percentage of participants who had achieved complete response (CR), partial response (PR), or stable disease (SD) lasting at least 12 weeks. According to RECIST v1.1 criteria: CR = disappearance of all target lesions, any pathological lymph nodes (whether target or on-target) must have reduction in short axis to <10 mm; PR = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions. | SAS included all participants who received at least one dose of Maplirpacept. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first Maplirpacept infusion till PD or death or censoring date, whichever occurred earlier (maximum up to 32 weeks) |
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| Secondary | Phase 1: Duration of Response (DOR) | DOR: for participants who achieved a confirmed CR or PR; defined as time from the date of first documented response (CR or PR) to the date of documented progression or death of any cause after achieving response. Participants who completed or discontinued the study without PD or death, as well as participants who received alternate anti-cancer therapy prior to PD, was censored at their last adequate response assessment date or last adequate assessment prior to start date of alternate anti-cancer therapy. CR=disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to <10 mm; PR=at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD= at least 20% increase in the sum of LD of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions. | Analysis of this outcome measure was to be evaluated in participants with confirmed CR or PR. Here, "Number of Participants Analyzed" = '0' signifies that no participant had confirmed CR or PR in any reporting arm. Hence, outcome measure not analyzed. | Posted | From time of first documented CR or PR to progression or death or censoring date, whichever occurred earlier (maximum up to 32 weeks |
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From start of treatment up to 30 days (+5) after last dose of study treatment (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks)
Same event may appear as both non-SAE and SAE but 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 set included all participants who received at least one dose of Maplirpacept.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Maplirpacept (PF-07901801) 12 mg/kg + PLD | Participants received Maplirpacept 12 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 IV on Day 1 of each 28-day cycle. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD | Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. | 0 | 4 | 1 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pyrexia | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vulval disorder | Reproductive system and breast disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Due to business decision the study was terminated, and Phase 2 of the study was not conducted. Hence, none of the section reports results for Phase 2 of the study. Data reported is only for Phase 1 of the study.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2023 | Oct 7, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| C041277 | 1-dodecylpyridoxal |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD | Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
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|
|
|
|
|
|
|
|
Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
| Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD |
Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
| OG001 |
| Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD |
Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle.
|
|
Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
| OG001 | Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD | Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
| Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD |
Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|
|
| OG001 | Phase 1: Maplirpacept (PF-07901801) 24 mg/kg + PLD | Participants received Maplirpacept 24 mg/kg by IV infusion on Days 1, 8, 15 and 22 of the 28-day for Cycle 1 and on Days 1 and 15 of subsequent 28-day cycles (Cycle 2 onward). Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
| OG002 | Phase 1: Maplirpacept (PF-07901801) 48 mg/kg + PLD | Participants received Maplirpacept 48 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle. Participants in combination received PLD 40 mg/m^2 intravenously on Day 1 of each 28-day cycle. |
|