A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.
• 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)
  • Virally associated tumors
• For Phase 2, participants must have one of the following solid tumors: (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
  • TMB-H
  • MSI-H/dMMR
  • CRC (both Ras wild type and mutant)
  • Virally associated tumors
  • Metastatic triple negative breast cancer
  • Platinum-resistant epithelial ovarian cancer
  • Metastatic castration-resistance prostate cancer
  • Primary stage IV or recurrent non-small cell lung cancer
  • Immunogenic solid tumors
• 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.

🚫 You may not be able to join if…

• 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.
• Major surgery or traumatic injury within 8 weeks before first dose of study drug.
• Unhealed wounds from surgery or injury.
• 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.
• Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
• Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
• Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
• Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
• 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.
• 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).
• 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 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

+ 20 more sites.

Who to contact

Ke Liu, MD, PhD · +1 (617) 917-4980 · kliu@marengotx.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05592626.