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