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A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

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Trial Profile

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Jun 2025

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At a glance

  • Drugs Dostarlimab (Primary)
  • Indications Adrenal cancer; Advanced breast cancer; Anal cancer; Biliary cancer; Carcinoma; Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Gallbladder cancer; Gastric cancer; Gastrointestinal cancer; Gynaecological cancer; Intestinal cancer; Liver cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Renal cell carcinoma; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms GARNET
  • Sponsors GlaxoSmithKline; GSK; TESARO

Most Recent Events

  • 30 Apr 2025 Results (n=67) assessing the effect of applying SerialCTRS to an expansion cohort of a single-arm phase 1 clinical trial of dostarlimab as 2nd line or greater therapy for advanced NSCLC (GARNET [cohort E] in predicting OS vs RECIST and tumor volume change, presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 03 Mar 2025 Planned primary completion date changed from 15 May 2026 to 18 May 2026.
  • 24 Jul 2024 According to a GlaxoSmithKline media release, base on results form A1 expansion cohort of GARNET trial, Health Canada granted full approval for Jemperli (dostarlimab for injection) as a monotherapy for the treatment of adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum containing regimen.

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