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A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation

Trial Profile

A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Mar 2026

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At a glance

  • Drugs D3S 003 (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors D3 Bio

Most Recent Events

  • 06 Mar 2026 Status changed from planning to not yet recruiting.
  • 16 Feb 2026 New trial record
  • 19 Jan 2026 According to D3 Bio media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared Investigational New Drug (IND) applications for D3S-003.

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