RecruitingPhase 1Phase 2NCT06827613

A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)


Sponsor

Marengo Therapeutics, Inc.

Enrollment

50 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of two cancer treatments — Invikafusp Alfa (an experimental drug that activates immune T cells) and sacituzumab govitecan (an antibody-drug conjugate) — for people with advanced breast cancer that has not responded to prior treatments. **You may be eligible if...** - You have advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive, HER2-negative breast cancer that has progressed or come back - Your cancer is measurable on a scan - If you have brain metastases, they must have been treated and be stable for at least 14 days **You may NOT be eligible if...** - You have active, untreated brain metastases causing symptoms - You have received certain prior treatments that overlap with this regimen (specific restrictions apply based on your cancer subtype) - You have significant other health conditions that could interfere with safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTAR0602

solution, intravenous infusion

DRUGSacituzumab Govitecan (SG)

intravenous infusion, 10mg/kg


Locations(8)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Health

Los Angeles, California, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

UT Health San Antonio MD Anderson Cancer Center

San Antonio, Texas, United States

BC Cancer

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06827613