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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
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose up to 3 years
Awards & highlights
No Placebo-Only Group

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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I am fully active or have some restrictions but can still take care of myself.
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My cancer is confirmed to be ovarian, fallopian tube, or peritoneal.
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My cancer got worse 1 to 6 months after my last platinum-based treatment.
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My cancer has worsened despite standard treatments, or I cannot tolerate them.
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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 cancer returned within 6 months after platinum treatment or I can't receive/declined further platinum therapy.
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My cancer has worsened despite standard treatments, or I cannot tolerate them.
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My organs and blood cells are working well.
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I have had 4 or fewer treatments for my platinum-resistant condition.
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My side effects from previous treatments are mild, except for hair loss or stable nerve pain.

Timeline

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
+1 more
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
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Trillium Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
594 Total Patients Enrolled
PfizerLead Sponsor
4,542 Previous Clinical Trials
10,145,296 Total Patients Enrolled
20 Trials studying Ovarian Cancer
2,967 Patients Enrolled for Ovarian Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,455 Previous Clinical Trials
7,326,619 Total Patients Enrolled
12 Trials studying Ovarian Cancer
2,433 Patients Enrolled for Ovarian Cancer

Media Library

Pegylated Liposomal Doxorubicin (PLD) (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05261490 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Phase 1: Dose Escalation, Phase 2: Dose Expansion
Ovarian Cancer Clinical Trial 2023: Pegylated Liposomal Doxorubicin (PLD) Highlights & Side Effects. Trial Name: NCT05261490 — Phase 1 & 2
Pegylated Liposomal Doxorubicin (PLD) (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05261490 — Phase 1 & 2
Ovarian Cancer Patient Testimony for trial: Trial Name: NCT05261490 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the overarching ambitions of this research endeavor?

"This medical trial will assess the efficacy of TTI-622 MTD or RP2D when combined with PLD over the course of 3 years. The primary outcome is to measure clinical activity, while secondary outcomes include duration of progression-free survival (PFS), time to progression and new metastases, and overall survival from study treatment initiation until death from any cause."

Answered by AI

Are researchers actively enrolling participants in this investigation?

"According to clinicaltrials.gov this current medical trial, which was first made available on August 1st 2022, is searching for participants and has recently been updated as of the 24th October 20202."

Answered by AI

Could you provide insight into the potential health risks of Pegylated Liposomal Doxorubicin?

"With Phase 2 clinical data indicating a certain degree of safety, our team at Power gave Pegylated Liposomal Doxorubicin a score of two on the risk scale."

Answered by AI

To what extent are hospitals administering this experiment?

"Recruitment for this trial is currently underway at 14 different medical sites, such as the Cleveland Clinic Fairview Hospital in Cleveland, UPMC Hillman Cancer Center-Investigational Drug Services in Pittsburgh, and Oklahoma Cancer Specialist and Research Institute LLC in Tulsa."

Answered by AI

What is the uppermost limit of individuals engaging in this clinical experiment?

"Correct. Clinicaltrials.gov's records demonstrate that this research, first posted on August 1st 2022, is in search of participants. This project demands 50 volunteers from 14 different medical sites."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
What site did they apply to?
Sarcoma Oncology Research Center, Cancer Center of Southern California
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

My doctor told me she has no more treatments for me unless if there’s any clinical trial that fits me.
PatientReceived 1 prior treatment
~0 spots leftby Feb 2024