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RecruitingPhase 1Phase 2NCT05592626

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

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

Sponsor

Marengo Therapeutics, Inc.

Enrollment

365 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid TumorsCarcinomaNeoplasmsNeoplasms by SiteLung NeoplasmGenital Neoplasm, FemaleUrogenital NeoplasmsPapillomavirus InfectionEpstein-Barr Virus InfectionsVulvar NeoplasmsVulvar DiseasesAbdominal Neoplasm

Summary

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental molecule called STAR0602, which is designed to activate immune cells called T cells to attack solid tumors. It is a first-in-human study testing safety and dosing in people with advanced cancers that have not responded to standard treatments. **You may be eligible if...** - You have a solid tumor that is advanced, has spread, or cannot be surgically removed, and standard treatments are no longer working - You have not received more than three prior treatment regimens for advanced disease - For Phase 1: your tumor has a high number of mutations (TMB-H), is microsatellite unstable (MSI-H), or is caused by a virus - For Phase 2: you have a specific tumor type identified by the study team **You may NOT be eligible if...** - You have a significant autoimmune disease (with some exceptions like mild skin conditions or controlled thyroid disease) - You have other serious conditions that would make participation unsafe 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

Locations(32)

Loma Linda University Cancer Center

Loma Linda, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

AdventHealth Celebration

Celebration, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

The University of Kansas Cancer Center

Kansas City, Kansas, United States

National Institutes of Health

Bethesda, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences, Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)

Nashville, Tennessee, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

UT Health Mays Cancer Center

San Antonio, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin- Madison

Madison, Wisconsin, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Research Institute of McGill University Health Centre

Montreal, Quebec, Canada

Hopsital Institut Curie

Paris, France, France

Oncopole Claudius Regaud IUCT

Toulouse, France, France

Institut Bergonié

Bordeaux, France

Centre Leon Berard

Lyon, France

Institute Gustave Roussy

Villejuif, France

Vall d'Hebron Institute of Oncology

Barcelona, Catalonia, Spain

Clinica Universidad de Navarra

San Blas-Canillejas, Madrid, Spain

Hospital Universitario Quirónsalud Madrid

Madrid, Spain, Spain

NEXT Oncology Barcelona, Hospital Quirónsalud Barcelona

Barcelona, Spain

START Madrid FJD

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Instituto de Investigacion Sanitaria, INCLIVA

Valencia, Spain

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NCT05592626

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