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A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia

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Trial Profile

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Bintrafusp alfa (Primary)
  • Indications Adenocarcinoma; Adenoid cystic carcinoma; Biliary cancer; Carcinoma; Colon cancer; Colorectal cancer; Gastric cancer; Liver cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Parotid cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Tongue cancer; Vulvovaginal cancer
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline; GSK; Merck KGaA

Most Recent Events

  • 26 Sep 2022 Results deriving PK and AE data from studies NCT02517398, NCT02699515, NCT03840915, and NCT04246489; describing a model-informed dose modification approach for risk management of Bintrafusp alfa associated bleeding adverse events, published in the Cancer Chemotherapy and Pharmacology
  • 07 Mar 2022 Status changed from active, no longer recruiting to completed.
  • 11 Apr 2021 Results (at data cutoff: 24 August 2018; n=30) of phase 1 cohort, published in the Targeted Oncology.

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