A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
NCT ID: NCT05592626
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
365 participants
INTERVENTIONAL
2023-01-04
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Advanced Solid Tumors
Dose Escalation; Intervention: Drug: STAR0602
STAR0602
solution, intravenous infusion
Phase 2: Advanced Solid Tumors
Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602
STAR0602
solution, intravenous infusion
Interventions
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STAR0602
solution, intravenous infusion
Eligibility Criteria
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Inclusion Criteria
2. For Phase 1, participants must have one of the following solid tumors:
1. High mutational burden (TMB-H)
2. Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
3. Virally associated tumors
3. For Phase 2, participants must have one of the following solid tumors:
1. TMB-H
2. MSI-H/dMMR
3. CRC (both Ras wild type and mutant)
4. Virally associated tumors
5. Metastatic triple negative breast cancer
6. Platinum-resistant epithelial ovarian cancer
7. Metastatic castration-resistance prostate cancer
8. Primary stage IV or recurrent non-small cell lung cancer
9. Immunogenic solid tumors
(Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
* No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent);
* No concurrent leptomeningeal disease or cord compression.
Exclusion Criteria
* Vitiligo;
* Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;
* History of Graves' disease, now euthyroid for \> 4 weeks;
* Hypothyroidism managed by thyroid replacement;
* Alopecia;
* Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.
* Adrenal insufficiency well controlled on replacement therapy.
2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.
3. Unhealed wounds from surgery or injury.
4. Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
5. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).
11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
18 Years
ALL
No
Sponsors
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Marengo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Guru Sonpavde, MD
Role: primary
Marijo Billusic, MD
Role: primary
Ryan Sullivan, MD
Role: primary
Joanne Charles
Role: primary
Victoria LaBush
Role: primary
Kai He, MD
Role: primary
Lillian Siu, MD
Role: primary
Audrey Laroche-Clary
Role: primary
Romain Di-Vincenzo
Role: primary
Gemma Mur
Role: primary
Manuel Pedregal
Role: primary
Other Identifiers
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CP-START-001
Identifier Type: -
Identifier Source: org_study_id
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