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 (START-002)
Summary
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.
Arms & interventions
- DrugSTAR0602
solution, intravenous infusion
- DrugSacituzumab Govitecan (SG)
intravenous infusion, 10mg/kg
Outcome measures
Primary
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
Time frame: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events
Time frame: Up to 3 years
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)
Time frame: Up to 3 years
Secondary
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)
Time frame: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602
Time frame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Eligibility criteria
Study locations (6)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Health
Los Angeles, California, 90095
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43212
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229