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Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors

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Trial Profile

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 23 Jan 2026

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At a glance

  • Drugs Zoldonrasib (Primary)
  • Indications Adenocarcinoma; Non-small cell lung cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions
  • Sponsors REVOLUTION Medicines

Most Recent Events

  • 08 Jan 2026 According to a Revolution Medicines media release, based on data from the monotherapy cohort of the phase 1 RMC-9805-001 clinical trial in adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to zoldonrasib.
  • 28 Aug 2025 Planned number of patients changed from 444 to 604.
  • 30 Apr 2025 Results assessing the preliminary safety and antitumor activity of zoldonrasib RMC-9805 in patients with KRAS G12D non-small cell lung cancer from a phase 1 study in advanced solid tumors were published at the 116th Annual Meeting of the American Association for Cancer Research.

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