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)
Summary
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.
Detailed description
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).
Arms & interventions
- DrugSTAR0602
solution, intravenous infusion
Outcome measures
Primary
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
Secondary
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)
Eligibility criteria
Study locations (18)
Loma Linda University Cancer Center
Loma Linda, California, 92354
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
AdventHealth Celebration
Celebration, Florida, 34747
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
The University of Kansas Cancer Center
Kansas City, Kansas, 66160
National Institutes of Health
Bethesda, Maryland, 20892
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Oklahoma Health Sciences, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville)
Nashville, Tennessee, 37203
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
UT Health Mays Cancer Center
San Antonio, Texas, 78229
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Wisconsin- Madison
Madison, Wisconsin, 53792