A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Phase 1/2
365
about 3.8 years
18+
18 sites in CA, CO, FL +11
What this study is about
This trial is testing the safety and how well a new drug called STAR0602 works in people with advanced solid tumors. The drug will be given as an injection into a vein. This is a phase 1/2 trial, meaning it's early research to see if the drug is safe and effective.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take STAR0602
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)
Secondary: Phase 1 and 2 (Dose Escalation and Expansion): Apparent Total Body Clearance (CL) for STAR0602, Phase 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration (AUC) Versus Time Curve for STAR0602, Phase 1 and 2 (Dose Escalation and Expansion): Duration of Responses (DOR), Phase 1 and 2 (Dose Escalation and Expansion): Maximum Observed Plasma Concentration (Cmax) for STAR0602, Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with Disease Control (CR, PR, and Stable Disease), Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with ORR, Phase 1 and 2 (Dose Escalation and Expansion): Terminal Elimination Half-life (t1/2) for STAR0602, Phase 1 and 2 (Dose Escalation and Expansion): Time (Tmax) to Reach the Maximum Plasma Concentration (Cmax) for STAR0602
Oncology, Infectious