Recruiting

Phase 1

Phase 2

D3S-001A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Sponsor:

D3 Bio (Wuxi) Co., Ltd

Code:

NCT05410145

Conditions

KRAS P.G12C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

D3S-001

Pembrolizumab

Cisplatin

Carboplatin

Pemetrexed

Study Details

Brief summary:

This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.

Conditions

KRAS P.G12C

Study ID

NCT05410145

Start date

Aug 3, 2022

Status verified date

Mar, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion:

Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
Subject 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:

Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).

Other protocol inclusion/exclusion criteria may apply

Study Design

Enrollment

442 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: D3S-001 monotherapy

Part 1: Dose Escalation, D3S-001 administered orally.

Part 2 and Part 3a Arm C: Dose Expansion, D3S-001 administered orally in selected cancer type patients.

Part 4a: Dose Optimization, D3S-001 administered orally in selected cancer type patients.

experimental: D3S-001 and pembrolizumab

Part 3a Arm A: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.

Pembrolizumab administered intravenously.

experimental: D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed)

Part 3a Arm B: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.

Cisplatin + pemetrexed administered intravenously

or

Carboplatin + pemetrexed administered intravenously

experimental: D3S-001 and Cetuximab

Part 3b: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.

Cetuximab administered intravenously.

Interventions

D3S-001

Oral

Pembrolizumab

Intravenous

Cisplatin

Intravenous

Carboplatin

Intravenous

Pemetrexed

Intravenous

Cetuximab

Intravenous

Primary outcome measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose until 30 days after the last dose (or specified in the protocol). ]
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 and Locations

Central contacts

Medical Director

+86 21 61635900 D3bio_CT@d3bio.com

Locations

D3 Bio Investigative Site 0402

Recruiting

Orange, California, United States, 92868

D3 Bio Investigative Site 0407

Recruiting

Palo Alto, California, United States, 94304-2205

D3 Bio Investigative Site 0404

Recruiting

Denver, Colorado, United States, 80218-1238

D3 Bio Investigative Site 0406

Recruiting

Sarasota, Florida, United States, 34232-6410

D3 Bio Investigative Site 0401

Recruiting

Detroit, Michigan, United States, 48202-2608

D3 Bio Investigative Site 0405

Recruiting

Nashville, Tennessee, United States, 37203

D3 Bio Investigative Site 0403

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

D3 Bio (Wuxi) Co., Ltd

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

KRAS p.G12C
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 2026-03-12.