This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.
Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer
Vitiligo
Psoriasis
Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment
History of Graves' disease, now euthyroid for > 4 weeks
Single group
STAR0602
Drugsolution, intravenous infusion
Sacituzumab Govitecan (SG)
Drugintravenous infusion, 10mg/kg
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)
Proportion of participants who have a complete response (CR) or partial response (PR)
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)
Proportion of participants who have a complete response (CR) or partial response (PR) or stable disease (SD)
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)
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