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Treatment with STAR0602 for 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)

Phase1; Phase2 Interventional Marengo Therapeutics, Inc. · NCT05592626

This study is testing a new treatment called STAR0602 to see if it can help people with advanced solid tumors by looking at how safe it is and how well it works.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment365 (estimated)
Ages18 Years and up
SexAll
SponsorMarengo Therapeutics, Inc. Industry-sponsored
Drugs / interventionsradiation, prednisone
Locations32 sites (Loma Linda, California and 31 other locations)
Trial IDNCT05592626 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1/2 study evaluates the safety and preliminary clinical activity of STAR0602, a bifunctional antibody-fusion molecule, administered intravenously to participants with advanced solid tumors that are rich in specific antigens. The study consists of two parts: Phase 1 focuses on dose escalation to determine the maximum tolerated dose, while Phase 2 involves administering the recommended dose to assess safety and clinical activity. Key outcomes include tumor response rates, duration of response, disease control rates, and progression-free survival.

Who should consider this trial

Good fit: Ideal candidates include individuals with unresectable, locally advanced, or metastatic solid tumors that are antigen-rich and have not responded to standard therapies.

Not a fit: Patients with solid tumors that are resectable or for which effective standard therapies exist may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.

How similar studies have performed: Other studies utilizing T cell receptor-targeting therapies have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Loma Linda, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.