Recruiting
Phase 1

D3S-003

Sponsor:

D3 Bio (Wuxi) Co., Ltd

Code:

NCT07456046

Conditions

KRAS P.G12D

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

D3S-003

Study Details

Brief summary:

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.

Conditions

KRAS P.G12D

Study ID

NCT07456046

Start date

May 29, 2026

Status verified date

Sep, 2026

Completion date

Jan 11, 2028

Anticipated

Primary completion date

Jan 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has failed to respond to adequate standard treatment(s), or for which no effective standard treatment is available.
  • Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years.
  • Subjects must have measurable disease per RECIST v1.1.
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject must have adequate organ and marrow function within the screening period.

Exclusion Criteria:

  • Participant has any prior treatment with a specific KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader.
  • Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent.
  • Uncontrolled or untreated brain metastases
  • Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy

NOTE: Other protocol inclusion/exclusion criteria may apply.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

D3S-003

Oral Tablet

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. ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: From screening visit until 30 days after the last dose (or specified in the protocol) ]
  • Maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs) [ Time Frame: First dose up to 7 months ]
  • Phase 2 dose (RP2D) [ Time Frame: First dose up to 7 months ]

Central Contacts and Locations

Central contacts

Medical Director

+86 21 61635900D3bio_CT@d3bio.com

Locations

D3 Bio Investigative Site 1404

Recruiting

New Haven, Connecticut, United States, 06511

D3 Bio Investigative Site 1403

Recruiting

Houston, Texas, United States, 77030

D3 Bio Investigative Site 1402

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

D3 Bio (Wuxi) Co., Ltd

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • KRAS P.G12D Mutation, Advanced solid tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by D3 Bio (Wuxi) Co., Ltd on 2026-09-08.