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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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)

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors (NCT05592626) is a Phase 1 / Phase 2 interventional studying Advanced Solid Tumors and Genital Neoplasm, Female, sponsored by Marengo Therapeutics, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Solid Tumors, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 365 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants must have diagnosed by tissue sample (biopsy-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 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. Who Should NOT Join This Trial: 1. Participants with a history of known autoimmune conditions (where your immune system attacks your own body) with exceptions of: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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 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: 1. Participants with a history of known autoimmune disease with exceptions of: * 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.

Treatments Being Tested

DRUG

STAR0602

solution, intravenous infusion

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05592626), the sponsor (Marengo Therapeutics, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05592626 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05592626?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05592626?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05592626. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05592626. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.