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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
solution, intravenous infusion
intravenous infusion, 10mg/kg
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUCLA Health
Los Angeles, California, United States
RECRUITINGMassachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
RECRUITINGOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGUT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, United States
RECRUITINGBC Cancer
Vancouver, British Columbia, Canada
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGPhase 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
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)
Proportion of participants who have a complete response (CR) or partial response (PR) or stable disease (SD)
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
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