Actively Recruiting
A Phase 1/2, First-in-Human, Open-Label Study of STAR0602, a Selective TCR Targeting Antibody-fusion Molecule, in Subjects With Advanced Antigen-rich Solid Tumors
Led by Marengo Therapeutics, Inc. · Updated on 2025-07-09
365
Participants Needed
32
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic
- Standard curative therapies do not exist, are ineffective, or have intolerable toxicities
- No more than three prior therapies for advanced or metastatic disease
- For Phase 1: tumors with high mutational burden, MSI-H/dMMR, or virally associated tumors
- For Phase 2: tumors with high mutational burden, MSI-H/dMMR, colorectal cancer (Ras wild type or 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
- Treated and asymptomatic central nervous system metastases for at least 14 days with no concurrent CNS treatment or active leptomeningeal disease
You will not qualify if you...
- History of autoimmune disease except controlled conditions like vitiligo or psoriasis not requiring systemic treatment
- Major surgery or traumatic injury within 8 weeks before first dose
- Unhealed wounds from surgery or injury
- Use of more than 10 mg prednisone (or equivalent) or immune-suppressive drugs within 7 days prior to study drug start, except certain topical or inhaled steroids
- Clinically significant cardiovascular, gastrointestinal, inflammatory, or pulmonary diseases
- Active infections requiring parenteral treatment within 7 days prior to study drug
- Live virus vaccination within 4 weeks prior to study drug
- Known HIV, hepatitis B or C positive with uncontrolled disease
- Second primary invasive malignancy not in remission for at least 1 year, except certain indolent cancers
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles up to 3 years or until discontinuation
Participants receive STAR0602 intravenously in repeated 28-day cycles to assess safety, tolerability, and clinical activity of the drug.
Visits occur at each treatment cycle with additional visits at Cycle 1, Cycle 3, and Cycle 6 for pharmacokinetic assessments
Duration - Up to 3 years after treatment
Participants are monitored for adverse events, disease response, and survival outcomes after treatment ends.
Periodic visits for monitoring up to 3 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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