A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
- Disease/Condition
- Neoplasms
- Drug/Device/Intervention
- TSR-022
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- GlaxoSmithKline
- Location
- Goodyear,Scottsdale,Tucson,Tucson,Encinitas,Fountain Valley,Los Angeles,Los Angeles,San Marcos,Whittier,Aurora,Aurora,Denver,Denver,New Haven,Washington,Jacksonville,Miami Beach,Sarasota,Tampa,Atlanta, South Korea,Spain,United States of America
- Phase
- Phase 1
- Start date
- Jul 08, 2016
- End date
- Feb 19, 2027
- Enrollment
- 475 participants
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs),Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs),Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs),Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs),Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications,Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing
 protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1
 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the
 recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of
 TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06322693
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT06322693 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Neoplasms. Target enrollment is 475 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.