A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.

Conditions

• KRAS P.G12D

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• D3S-003 — DRUG
  Oral Tablet

Study Details

This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.

Key Dates

Start date

May 29, 2026

Status verified

Jun 2026

Primary completion

Jan 11, 2028

Completion

Jan 11, 2028

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: D3S-003
  Part 1a Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Once Daily Dosing) Part 1b Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Twice Daily Dosing)

Primary Outcome Measure

Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days. ]

Central Contacts

• Medical Director
  +86 21 61635900
  [email protected]

Locations (1)

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