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A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation

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Trial Profile

A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Oct 2025

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At a glance

  • Drugs KQB 548 (Primary) ; Antineoplastics
  • Indications Adenocarcinoma; Colorectal cancer; Non-small cell lung cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions
  • Sponsors Kumquat Biosciences

Most Recent Events

  • 09 Oct 2025 New trial record
  • 12 Aug 2025 According to Bayer media release, Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025.
  • 12 Aug 2025 According to Bayer media release, company entered into an exclusive global license and collaboration to develop and commercialize KRAS G12D inhibitor and under the agreement, Kumquat is responsible for the initiation and completion of the phase Ia study, while Bayer will complete development and commercial activities.

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