Actively Recruiting
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Led by Marengo Therapeutics, Inc. · Updated on 2025-07-09
365
Participants Needed
32
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities.
- Participants should not have received more than three lines of prior therapies for their advanced or metastatic diseases.
- For Phase 1, participants must have one of the following solid tumors: High mutational burden (TMB-H), Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR), or virally associated tumors.
- For Phase 2, participants must have one of the following solid tumors: TMB-H, MSI-H/dMMR, colorectal cancer (both Ras wild type and mutant), virally associated tumors, metastatic triple negative breast cancer, platinum-resistant epithelial ovarian cancer, metastatic castration-resistant prostate cancer, primary stage IV or recurrent non-small cell lung cancer, or immunogenic solid tumors.
- Symptomatic central nervous system metastases must have been treated, be asymptomatic for at least 14 days, and have no concurrent treatment for CNS disease, leptomeningeal disease, or cord compression at enrollment.
You will not qualify if you...
- History of known autoimmune disease except for vitiligo; psoriasis, atopic dermatitis, or other autoimmune skin conditions not requiring systemic treatment; euthyroid Graves' disease for more than 4 weeks; hypothyroidism managed by thyroid replacement; alopecia; arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs; or adrenal insufficiency well controlled on replacement therapy.
- Major surgery or traumatic injury within 8 weeks before first dose of study drug.
- Unhealed wounds from surgery or injury.
- Treatment with more than 10 mg per day of prednisone or other immune-suppressive drugs within 7 days prior to study drug initiation, except for certain allergic reactions.
- Clinically significant cardiovascular, gastrointestinal, inflammatory, or pulmonary disorders.
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to study drug initiation.
- Vaccination with any live virus vaccine within 4 weeks prior to study drug administration.
- Known HIV positive or hepatitis B or C positive with uncontrolled disease.
- Second primary invasive malignancy not in remission for at least 1 year, with specific exceptions.
- Pregnant, likely to become pregnant, or lactating women.
- Hepatic metastases unless adequately treated and stable for 3 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
Actively Recruiting
2
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
4
AdventHealth Celebration
Celebration, Florida, United States, 34747
Actively Recruiting
5
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
6
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
National Institutes of Health
Bethesda, Maryland, United States, 20892
Actively Recruiting
8
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
12
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
University of Oklahoma Health Sciences, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
14
Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
UT Health Mays Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
17
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
18
University of Wisconsin- Madison
Madison, Wisconsin, United States, 53792
Actively Recruiting
19
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
20
Research Institute of McGill University Health Centre
Montreal, Quebec, Canada, H3H 2R9
Actively Recruiting
21
Hopsital Institut Curie
Paris, France, France, 75248
Actively Recruiting
22
Oncopole Claudius Regaud IUCT
Toulouse, France, France, 31100
Actively Recruiting
23
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
24
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
25
Institute Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
26
Vall d'Hebron Institute of Oncology
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
27
Clinica Universidad de Navarra
San Blas-Canillejas, Madrid, Spain, 28027
Actively Recruiting
28
Hospital Universitario Quirónsalud Madrid
Madrid, Spain, Spain, 28223
Actively Recruiting
29
NEXT Oncology Barcelona, Hospital Quirónsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
30
START Madrid FJD
Madrid, Spain, 28040
Actively Recruiting
31
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
32
Instituto de Investigacion Sanitaria, INCLIVA
Valencia, Spain, 46010
Actively Recruiting
Research Team
K
Ke Liu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here