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An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics,Pharmacodynamics and Preliminary Antitumor Activity of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

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Trial Profile

An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics,Pharmacodynamics and Preliminary Antitumor Activity of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Sep 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; TAK-500 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Gastric cancer; Head and neck cancer; Liver cancer; Mesothelioma; Nasopharyngeal cancer; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions
  • Sponsors Takeda

    • Most Recent Events

    • 20 Nov 2023 Change in phase,design term, treatment arms,timeframe of primary endpointsand addition of ORR endpoint.
    • 20 Nov 2023 Planned number of patients changed from 118 to 313.
    • 20 Nov 2023 Planned End Date changed from 20 Mar 2025 to 11 Aug 2026.

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