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NCT06048705Terminated

Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer

Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NYESO1 and LAGE1a, and Co-expressing CD8α (GSK3901961) in Participants With NYESO1 and/or LAGE1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma / Myxoid/Round Cell Liposarcoma; or NYESO1 and/or LAGE1a Positive Previously Treated Metastatic Non-Small Cell Lung Cancer
GlaxoSmithKlinePhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Neoplasms
Drug/Device/Intervention
GSK3901961
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
New Haven,Jacksonville,Tampa,Atlanta,Westwood,Lexington,Baltimore,Saint Louis,New York,New York,Philadelphia,Houston,Melbourne,Toronto,Montréal,Muenchen,Hannover,Koeln,Dresden,Amsterdam,Stockholm, Australia,Canada,Germany,Netherlands,Sweden,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 09, 2021
End date
May 26, 2023
Enrollment
7 participants
Primary outcome

Number of Participants with Dose Limiting Toxicities (DLTs),Number of Participants with Adverse Events (AEs), Serious AEs and Adverse Events of Special Interest (AESI) based on Severity

Summary

The primary purpose of this sub study is to assess the safety, tolerability and determine
 recommended Phase 2 dose (RP2D) of GSK3901961 in HLA A*02:01, HLA-A*02:05 and/or HLA A*02:06
 positive participants with New York esophageal squamous cell carcinoma (NY ESO 1) and/or
 Cancer testis antigen 2 (LAGE 1a) positive previously treated metastatic Non-Small Cell Lung
 Cancer (NSCLC) and previously treated, advanced (metastatic or unresectable) Synovial
 Sarcoma/ Myxoid/Round Cell Liposarcoma SS/MRCLS.

ICD-10 classifications
NeoplasmsIn situ neoplasmsPersonal history of other neoplasmsBenign neoplasmsMalignant neoplasms
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06048705
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06048705 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Terminated. The study focuses on Neoplasms. Target enrollment is 7 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.