Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Epithelial Ovarian Cancer (EOC), Ovarian Cancer, Platinum-Resistant Ovarian Cancer, Cluster of Differentiation 47 (CD47), maplirpacept (PF-07901801), TTI-622, Doxorubicin, Immune-oncology, chemotherapy, anti-SIRPα therapy
Eligibility Criteria
Key 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 disease (progression ≥1 month and ≤6 months after a minimum of four cycles of last platinum-based treatment)
- 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.
Key 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.
Sites / Locations
- Sarcoma Oncology Research Center
- Baptist Hospital of Miami
- Miami Cancer Institute at Baptist Health, Inc.
- Orlando Health Cancer Institute Gynecologic Cancer Center
- Orlando Health Cancer Institute
- Michigan Healthcare Professionals PC
- Michigan Healthcare Professionals PC
- Michigan Healthcare Professionals PC
- Michigan Healthcare Professionals PC
- Cleveland Clinic taussig Cancer Center Investigational Pharmacy
- Cleveland Clinic Fairview Hospital
- Cleveland Clinic
- Cleveland Clinic Hillcrest Hospital
- Oklahoma Cancer Specialist and Research Institute. LLC
- Magee-Womens Hospital of UPMC
- UPMC Hillman Cancer Center-Investigational Drug Services
- Avera Cancer Institute
- oncology Consultants, P.A.
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1: Dose Escalation
Phase 2: Dose Expansion
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.
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.