Actively Recruiting
A Phase 12, 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 12 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
Research Team
K
Ke Liu, MD, PhD
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