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NCT05943990Terminated

Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NY ESO 1 and LAGE 1a, and Co-expressing the dnTGF-βRII (GSK3845097) in Participants With NY ESO 1 and/or LAGE 1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
GlaxoSmithKlinePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Neoplasms
Drug/Device/Intervention
GSK3845097
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
Dec 21, 2020
End date
Oct 24, 2022
Enrollment
5 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

To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of
 GSK3845097 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, advanced (metastatic or unresectable) Synovial Sarcoma (SS) and
 Myxoid/Round Cell Liposarcoma (MRCLS).

ICD-10 classifications
NeoplasmsIn situ neoplasmsPersonal history of other neoplasmsBenign neoplasmsMalignant neoplasms
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05943990
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05943990 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 5 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.