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 and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.
This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
solution, intravenous infusion
solution, intravenous infusion
solution, intravenous infusion
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGAdventHealth Celebration
Celebration, Florida, United States
RECRUITINGUniversity of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
ACTIVE_NOT_RECRUITINGThe University of Kansas Cancer Center
Kansas City, Kansas, United States
RECRUITINGNational Institutes of Health
Bethesda, Maryland, United States
RECRUITINGMassachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGThe Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGSarah Cannon Research Institute Oncology Partners (SCRI-Nashville)
Nashville, Tennessee, United States
RECRUITINGThe University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 9 more locations
Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
Time frame: Cycle 1 (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)
Complete response (CR) and partial response (PR)
Time frame: Up to 3 years
Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with ORR
Time frame: Up to 3 years
Phase 1 and 2 (Dose Escalation and Expansion): Duration of Responses (DOR)
Time frame: Up to 3 years
Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with Disease Control (CR, PR, and Stable Disease)
Time frame: Up to 3 years
Phase 2 (Dose Expansion): Progression Free Survival (PFS)
Time frame: Up to 3 years
Phase 2 (Dose Expansion): Overall Survival (OS)
Time frame: Up to 3 years
Phase 1 and 2 (Dose Escalation and Expansion): Maximum Observed Plasma Concentration (Cmax) for STAR0602
Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Time (Tmax) to Reach the Maximum Plasma Concentration (Cmax) for STAR0602
Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration (AUC) Versus Time Curve for STAR0602
Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Terminal Elimination Half-life (t1/2) for STAR0602
Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Apparent Total Body Clearance (CL) for STAR0602
Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Apparent Volume of Distribution (Vd) for STAR0602
Time frame: Dose Escalation: Cycle 1 and Cycle 6 at predefined intervals up to 1 year; Dose Expansion: Cycle 1, Cycle 3, and Cycle 6 at predefined intervals up to 3 years (Cycle length= 28 days)
Phase 1 and 2 (Dose Escalation and Expansion): Anti-drug Antibody (ADA) formation
Time frame: Dose Escalation and Expansion: Day 1 of predetermined cycles up to 3 years (Cycle length= 28 days)
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