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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 30, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07902921). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 67 participants (ESTIMATED). Conditions: NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, Prostate Cancer, Thymic Epithelial Tumors, TETs, Thymic Carcinomas, Thymomas, Metastatic Castrate-resistant Prostate Cancer, mCRPC. Interventions: DRUG: STAR0602; DRUG: Nivolumab. Primary outcome measures: Phase Ib: Determine the safety of STAR0602 monotherapy in participants with TC, and safety of STAR0602 in combination with nivolumab in participants with NSCLC with or without targetable genomic alterations or mCRPC , Start of therapy through 90 day post last dose safety visit.; Phase II: Determine the clinical efficacy of STAR0602 alone in participants with TC measured by progression free survival (PFS) , Cycle 3 Day 1, Cycle 4 Day 1, then every 8 weeks for the first year and every 12 weeks thereafter until disease progression, start of another systemic therapy, or 5 years after completion of study treatment.. Brief summary: Background: Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). But these cancers may still come back after treatment. Objective: To test a new immunotherapy drug (STAR0602), alone or combined with an approved drug (nivolumab), in people with NSCLC, mCRPC, or TC. Eligibility: People aged 18 years or older with NSCLC, mCRPC, or TC that did not respond to treatment or returned after treatment. Design: Participants will be screened. They will have blood and urine tests. They will have imaging scans and a test of their heart function. STAR0602 and nivolumab are given through a needle inserted into a vein (infusion). Participants will be treated in 28-day cycles. They will receive infusions of 1 or both drugs on the first and 15th day of each cycle. They will remain in the hospital for up to 5 days after their first 2 infusions of STAR0602. Imaging scans, blood tests, and other tests may be repeated during study visits. Participants may opt to have tissue samples (biopsies) taken from their tumors. Some blood and tissue samples may be used for genetic tests. Participants may continue getting STAR0602 for up to 2 years and nivolumab for up to 6 months. Participants will have an end-of-study visit within 1 month, and follow-up phone calls 1 month and 3 months, after they stop the study drug. Long-term follow-up calls and visits will continue every 3 to 6 months for up to 5 years.