NCT05592626 · Marengo Therapeutics, Inc.
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
(START-001)
What this study is about
This is an open label, conducted at multiple hospitals, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered given through a vein (IV) in participants with advanced solid tumors that are antigen-rich.
View original scientific description
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.
Interventions
DRUG
STAR0602
solution, intravenous infusion
Primary outcome measures
Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
Time frame: Cycle 1 (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)
Time frame: Up to 3 years
Complete response (CR) and partial response (PR)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases. 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 soli
Where
- Loma Linda, California
- Sacramento, California
- Denver, Colorado
- Celebration, Florida
- Miami, Florida
- Kansas City, Kansas
- Bethesda, Maryland
- Boston, Massachusetts
- Detroit, Michigan
- New York, New York
- Columbus, Ohio
- Oklahoma City, Oklahoma
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2025 · Source of record for eligibility and locations