Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer

NCT ID: NCT05261490

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-02-15

Brief Summary

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).

Detailed Description

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.

Conditions

Ovarian Cancer; Ovarian Neoplasms; Ovarian Carcinoma; Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1: Dose Escalation

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.

Group Type: EXPERIMENTAL

maplirpacept (PF-07901801)

Intervention Type: 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.

Pegylated Liposomal Doxorubicin (PLD)

Intervention Type: DRUG

RP2D of maplirpacept (PF-07901801) biweekly of maplirpacept (PF-07901801) from Phase 1 escalation in combination with pegylated liposomal doxorubicin 40mg/m2

Phase 2: Dose Expansion

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.

Group Type: EXPERIMENTAL

maplirpacept (PF-07901801)

Intervention Type: 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.

Pegylated Liposomal Doxorubicin (PLD)

Intervention Type: DRUG

RP2D of maplirpacept (PF-07901801) biweekly of maplirpacept (PF-07901801) from Phase 1 escalation in combination with pegylated liposomal doxorubicin 40mg/m2

Interventions

maplirpacept (PF-07901801)

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.

Intervention Type: DRUG

Pegylated Liposomal Doxorubicin (PLD)

RP2D of maplirpacept (PF-07901801) biweekly of maplirpacept (PF-07901801) from Phase 1 escalation in combination with pegylated liposomal doxorubicin 40mg/m2

Intervention Type: DRUG

Other Intervention Names

TTI-622; PLD

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Histologically-confirmed epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC).
• Platinum-resistant recurrent (disease progression ≤6 months after the most recent platinum-based treatment regimen (date calculated from the last administered dose of platinum) or the participant is no longer able to receive.

or declined treatment with platinum-based chemotherapy.

• Progression with standard of care therapies, including platinum-based therapies, poly ADP ribose polymerase (PARP) inhibitors or bevacizumab in the platinum-sensitive setting or intolerability to such therapies or patient refusal
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Adequate organ and hematologic function
• No more than four prior treatment regimens for platinum-resistant disease
• All adverse events from prior treatment must be the Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.

Exclusion Criteria

• Platinum-refractory disease (defined as progression on or within 3 months of completing primary first-line platinum-based treatment)
• Non-epithelial histology, including malignant mixed Mullerian tumors
• Ovarian tumors with low malignant potential (i.e., borderline tumors), low grade serous ovarian cancer or carcinosarcoma
• History of acute coronary syndromes.
• History of or current Class II, III, or IV heart failure.
• History or evidence of known central nervous system (CNS) metastases or carcinomatous meningitis.
• Significant bleeding disorders, vasculitis or a significant bleeding episode from the Gastrointestinal (GI) tract.
• History of severe hypersensitivity reactions to antibodies.
• Systemic steroid therapy.
• History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs.
• Prior organ transplantation including allogenic or autologous stem cell transplantation
• Prior treatment with anti-cluster of differentiation 47 (CD47) or anti-SIRPα therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Sarcoma Oncology Research Center

Santa Monica, California, United States

Baptist Hospital of Miami

Miami, Florida, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Orlando Health Cancer Institute Gynecologic Cancer Center

Orlando, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Michigan Healthcare Professionals PC

Dearborn, Michigan, United States

Michigan Healthcare Professionals PC

Farmington Hills, Michigan, United States

Michigan Healthcare Professionals PC

Royal Oak, Michigan, United States

Michigan Healthcare Professionals PC

Sterling Heights, Michigan, United States

Cleveland Clinic taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, United States

Oklahoma Cancer Specialist and Research Institute. LLC

Tulsa, Oklahoma, United States

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center-Investigational Drug Services

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

oncology Consultants, P.A.

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=TTI-622-02

To obtain contact information for a study center near you, click here.

Other Identifiers

C4971002

Identifier Type: OTHER

Identifier Source: secondary_id

TTI-622-02

Identifier Type: -

Identifier Source: org_study_id