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)
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.
• 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:
∙ 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
• (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
• 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.