Ontorpacept + Doxorubicin for Leiomyosarcoma
(TTI-621-03 Trial)

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Trillium Therapeutics Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called Ontorpacept, alone and with doxorubicin, in people with advanced leiomyosarcoma. Ontorpacept helps the immune system fight cancer, and doxorubicin kills cancer cells. The study aims to see if this combination is safe and effective.

Eligibility Criteria

This trial is for people with advanced leiomyosarcoma, a type of muscle tumor, who haven't been treated with anthracyclines and have had at most one other treatment. Participants should be in good overall health with no severe allergies to antibodies or history of certain autoimmune diseases or organ transplants.

Inclusion Criteria

Adequate organ and hematologic function

Patients who were treated with a prior chemotherapy regimen must have completed treatment at least three weeks before initiation of study treatment

All adverse events from prior treatment must be NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline

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Exclusion Criteria

You have received treatment with a specific type of medication called anti-CD47 or anti-SIRPα therapy before.

You have a history of serious heart problems.

You have or have had serious heart problems that affect how well your heart pumps blood.

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Treatment Details

Interventions

Doxorubicin (Anti-tumor antibiotic)
TTI-621 (Monoclonal Antibodies)

Trial OverviewThe study tests Ontorpacept (TTI-621) alone and combined with Doxorubicin in treating leiomyosarcoma. Initially, both drugs are given by IV every three weeks for 18 weeks; afterwards, only Ontorpacept is continued biweekly until it's not effective anymore.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Dose Expansion Dose Level C (Cohort C)Experimental Treatment2 Interventions

Participants with high-grade leiomyosarcoma will receive up to six cycles of Ontorpacept (TTI-621) at a pre-specified dose level (Dose Level C) in combination with fixed-dose doxorubicin followed by Ontorpacept (TTI-621) monotherapy to further characterize safety, tolerability, and clinical activity of the treatment regimen.

Group II: Dose Expansion Dose Level B (Cohort B)Experimental Treatment2 Interventions

Participants with high-grade leiomyosarcoma will receive up to six cycles of Ontorpacept (TTI-621) at a pre-specified dose level (Dose Level B) in combination with fixed-dose doxorubicin followed by Ontorpacept (TTI-621) monotherapy to further characterize safety, tolerability, and clinical activity of the treatment regimen.

Group III: Dose Expansion Dose Level A (Cohort A)Experimental Treatment2 Interventions

Participants with high-grade leiomyosarcoma will receive up to six cycles of Ontorpacept (TTI-621) at a pre-specified dose level (Dose Level A) in combination with fixed-dose doxorubicin followed by Ontorpacept (TTI-621) monotherapy to further characterize safety, tolerability, and clinical activity of the treatment regimen.

Group IV: Dose Escalation (Ontorpacept+doxorubicin)Experimental Treatment2 Interventions

In the dose escalation portion of the study, participants with specific subsets of soft tissue sarcomas who have not received more than one prior line of therapy and have not received an anthracycline in any setting will be enrolled in three escalating dose cohorts to characterize the safety and tolerability of Ontorpacept (TTI-621) when administered in combination with doxorubicin for up to six cycles and followed by Ontorpacept (TTI-621) monotherapy

Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Adriamycin for: