Trial Profile

A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S 001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS P.G12C Mutation

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 26 Jun 2025

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At a glance

Drugs Carboplatin (Primary) ; Cetuximab (Primary) ; Cisplatin (Primary) ; D3S-001 (Primary) ; Pembrolizumab (Primary) ; Pemetrexed (Primary)
Indications Adenocarcinoma; Colorectal cancer; Ductal carcinoma; Non-small cell lung cancer; Pancreatic cancer; Solid tumours
Focus Adverse reactions; First in man
Sponsors D3 Bio

03 Jun 2025 Planned number of patients changed from 392 to 442.
03 Jun 2025 Planned End Date changed from 1 Sep 2026 to 1 Feb 2027.
03 Jun 2025 Planned primary completion date changed from 1 Sep 2026 to 1 Feb 2027.

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