What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as pegylated liposomal doxorubicin (PLD), bevacizumab, and PARP inhibitors (e.g., olaparib, niraparib, rucaparib), have several known side effects. PLD is associated with myelotoxicity, including neutropenia and thrombocytopenia, as well as hand-foot syndrome and stomatitis. Bevacizumab can cause hypertension, proteinuria, and an increased risk of gastrointestinal perforation. PARP inhibitors often lead to nausea, fatigue, vomiting, and anemia. These side effects are important considerations when evaluating the safety and efficacy of combination treatments like Maplirpacept (PF-07901801) with PLD.

What prior FDA approvals exist?

The FDA has approved pegylated liposomal doxorubicin (PLD) as a standard treatment for platinum-resistant ovarian cancer, with response rates between 12 to 35%. Additionally, the combination of PLD with bevacizumab, an anti-angiogenic monoclonal antibody, has been approved to enhance the efficacy of PLD in treating this condition. These treatments aim to provide more effective therapeutic options for patients with platinum-resistant ovarian cancer.

What other types of research exist?

Promising alternatives to Maplirpacept (PF-07901801) combined with PLD for treating platinum-resistant ovarian cancer include: 1) PARP inhibitors such as Olaparib, which have shown significant improvement in progression-free survival (PFS) in patients with BRCA mutations. 2) Bevacizumab combined with chemotherapy, which is FDA-approved and has demonstrated efficacy in this patient group. 3) Pembrolizumab combined with chemotherapy, which has shown improved PFS and overall survival (OS) in clinical trials for recurrent or metastatic ovarian cancer.

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Chemotherapy

Maplirpacept + PLD for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Trillium Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platinum-resistant disease (progression ≥1 month and ≤6 months after a minimum of four cycles of last platinum-based treatment)

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose up to 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, TTI-622, in combination with an existing cancer drug, Pegylated liposomal doxorubicin. The trial will enroll approximately 50 patients in two phases to test different doses of the new drug.

Who is the study for?

This trial is for women with platinum-resistant ovarian cancer, including cancers of the ovary, fallopian tube, or peritoneum. Participants should have measurable disease and be in good physical condition (ECOG 0-1), with proper organ function. They must have progressed after standard treatments or cannot tolerate them. Women who've had more than four prior treatments for their resistant disease or those with certain heart conditions, CNS metastases, severe bleeding disorders, hypersensitivity to antibodies, or autoimmune diseases requiring intense treatment are excluded.Check my eligibility

What is being tested?

The study tests maplirpacept combined with Pegylated Liposomal Doxorubicin (PLD) chemotherapy in patients who haven't responded well to platinum-based therapies. Initially, it will determine the safest dose of maplirpacept to use alongside PLD by gradually increasing doses. Once a safe combination is found, more participants will receive this regimen over 28-day cycles until they experience significant side effects or their disease worsens.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system due to maplirpacept such as inflammation in various organs and infusion-related reactions; from PLD there may be fatigue, digestive issues like nausea and mouth sores; skin problems like hand-foot syndrome; low blood counts leading to increased infection risk; and potential heart toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer got worse 1 to 6 months after my last platinum-based treatment.

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I am fully active or can carry out light work.

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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

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My side effects from previous treatments are mild, except for hair loss or stable nerve pain.

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I have had 4 or fewer treatments for my platinum-resistant condition.

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My cancer is confirmed to be ovarian, fallopian tube, or peritoneal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess preliminary evidence of anti-tumor activity of (RP2D) maplirpacept (PF-07901801) in combination with 40 mg/m2 PLD (Phase 2 portion of study)

Evaluate DLTs (number) of each escalating dose level of cycle 1 of maplirpacept (PF-07901801) when administered in combination with 40 mg/m2 PLD in 28-day cycles in the Phase 1 escalation

Identify the Recommended Phase 2 Dose (RP2D) from the Phase 1 Escalation Phase

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Secondary outcome measures

Assess Disease Control (DC) [CR+PR+SDS] of maplirpacept (PF-07901801) (RP2D) in combination with PLD 40mg/m2 in 28-day cycle in the Phase 2 expansion

Assess Duration of progression-free survival (PFS) of maplirpacept (PF-07901801) (RP2D) in combination with PLD 40mg/m2 in 28-day cycle in the Phase 2 expansion

Assess Duration of response (DOR) of maplirpacept (PF-07901801) (RP2D) in combination with PLD 40mg/m2 in 28-day cycle in the Phase 2 expansion

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Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions

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 II: Phase 1: Dose EscalationExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegylated Liposomal Doxorubicin (PLD)

2016

Completed Phase 2

~90

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pegylated Liposomal Doxorubicin (PLD) works by intercalating DNA, disrupting replication and transcription, which leads to cell death. Its liposomal formulation allows for better targeting of cancer cells and reduced toxicity. PARP inhibitors, such as Olaparib, inhibit the PARP enzyme involved in DNA repair, causing cancer cells with BRCA mutations to accumulate DNA damage and die. Bevacizumab, an anti-angiogenesis agent, inhibits vascular endothelial growth factor (VEGF), reducing blood supply to tumors and inhibiting their growth. These mechanisms are crucial for ovarian cancer patients as they target cancer cells more effectively, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation BRCA1-Del ex9-12.Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial.