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Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma - Trial NCT05943990

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.

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NCT05943990
Phase 1
Terminated
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05943990
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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-ฮฒRII (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

Study Focus

Neoplasms

GSK3845097

Interventional

drug

Sponsor & Location

GlaxoSmithKline

New Haven,Jacksonville,Tampa,Atlanta,Westwood,Lexington,Baltimore,Saint Louis,New York,New York,Philadelphia,Houston,Melbourne,Toronto,Montrรฉal,Muenchen,Hannover,Koeln,Dresden,Amsterdam,Stockholm, Australia,Canada,Germany,Netherlands,Sweden,United States of America

Timeline & Enrollment

Phase 1

Dec 21, 2020

Oct 24, 2022

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

Neoplasms
In situ neoplasms
Personal history of other neoplasms
Benign neoplasms
Malignant neoplasms

Data Source

ClinicalTrials.gov

NCT05943990

Non-Device Trial