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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

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: 24 Aug 2023

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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

    • 01 Jul 2023 Results of efficacy and safety of dostarlimab in a UK specific population of cohort F with subgroup analysis in patients with colorectal cancer (CRC), presented at the 25th World Congress on Gastrointestinal Cancer
    • 23 Feb 2023 Results(n=377 of GARNET Part 2B) assessing dostarlimab's effect on corrected QT (QTc) interval and the systemic concentration-QTc interval relationship published in the British Journal of Clinical Pharmacology
    • 09 Feb 2023 According to a GlaxoSmithKline media release, US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation, based on this trial.
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