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A Phase 1a/b, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors

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Trial Profile

A Phase 1a/b, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs IBI 343 (Primary)
  • Indications Adenocarcinoma; Biliary cancer; Gastric cancer; Oesophageal cancer; Pancreatic cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Innovent Biologics

Most Recent Events

  • 02 Jun 2025 According to an Innovent Biologics media release, data from the study were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • 02 Jun 2025 Results presented in the Innovent Biologics Media Release
  • 16 Jan 2025 According to an Innovent Biologics media release, based on results form this trial the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343 as monotherapy for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment.

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