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NCT06322693Recruiting

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)
GlaxoSmithKlinePhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Neoplasms
Drug/Device/Intervention
TSR-022
Study type
Interventional
Intervention type
drug
Sponsor & location
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
Timeline & enrollment
Phase
Phase 1
Start date
Jul 08, 2016
End date
Feb 19, 2027
Enrollment
475 participants
Primary outcome

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

Summary

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.

ICD-10 classifications
NeoplasmsIn situ neoplasmsPersonal history of other neoplasmsBenign neoplasmsMalignant neoplasms
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06322693
Type
Non-Device Trial
About this record

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.