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

NCT ID: NCT05410145

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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KRAS P.G12C

Keywords

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KRAS p.G12C Mutation advanced solid tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

D3S-001

Intervention Type DRUG

Oral

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.

Group Type EXPERIMENTAL

D3S-001

Intervention Type DRUG

Oral

Pembrolizumab

Intervention Type DRUG

Intravenous

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

Group Type EXPERIMENTAL

D3S-001

Intervention Type DRUG

Oral

Cisplatin

Intervention Type DRUG

Intravenous

Carboplatin

Intervention Type DRUG

Intravenous

Pemetrexed

Intervention Type DRUG

Intravenous

D3S-001 and Cetuximab

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

Cetuximab administered intravenously.

Group Type EXPERIMENTAL

D3S-001

Intervention Type DRUG

Oral

Cetuximab

Intervention Type DRUG

Intravenous

Interventions

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D3S-001

Oral

Intervention Type DRUG

Pembrolizumab

Intravenous

Intervention Type DRUG

Cisplatin

Intravenous

Intervention Type DRUG

Carboplatin

Intravenous

Intervention Type DRUG

Pemetrexed

Intravenous

Intervention Type DRUG

Cetuximab

Intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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D3 Bio (Wuxi) Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng Chen, MD

Role: STUDY_DIRECTOR

D3 Bio (Wuxi) Co., Ltd

Locations

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D3 Bio Investigative Site 0402

Orange, California, United States

Site Status RECRUITING

D3 Bio Investigative Site 0407

Palo Alto, California, United States

Site Status RECRUITING

D3 Bio Investigative Site 0404

Denver, Colorado, United States

Site Status RECRUITING

D3 Bio Investigative Site 0406

Sarasota, Florida, United States

Site Status RECRUITING

D3 Bio Investigative Site 0401

Detroit, Michigan, United States

Site Status RECRUITING

D3 Bio Investigative Site 0405

Nashville, Tennessee, United States

Site Status RECRUITING

D3 Bio Investigative Site 0403

Houston, Texas, United States

Site Status RECRUITING

D3 Bio Investigative Site 0102

Sydney, New South Wales, Australia

Site Status RECRUITING

D3 Bio Investigative Site 0101

Malvern, Victoria, Australia

Site Status RECRUITING

D3 Bio Investigative Site 0105

Melbourne, Victoria, Australia

Site Status RECRUITING

D3 Bio Investigative Site 0103

Nedlands, Western Australia, Australia

Site Status RECRUITING

D3 Bio Investigative Site 0104

Bedford Park, , Australia

Site Status RECRUITING

D3 Bio Investigative Site 0303

Beijing, Beijing Municipality, China

Site Status RECRUITING

D3 Bio Investigative Site 0306

Guangzhou, Guangdong, China

Site Status RECRUITING

D3 Bio Investigative Site 0305

Hangzhou, Hangzhou, China

Site Status RECRUITING

D3 Bio Investigative Site 0307

Harbin, Heilongjiang, China

Site Status RECRUITING

D3 Bio Investigative Site 0309

Wuhan, Hubei, China

Site Status RECRUITING

D3 Bio Investigative Site 0312

Wuhan, Hubei, China

Site Status RECRUITING

D3 Bio Investigative Site 0304

Nanchang, Jiangxi, China

Site Status RECRUITING

D3 Bio Investigative Site 0302

Shenyang, Liaoning, China

Site Status RECRUITING

D3 Bio Investigative Site 0310

Jinan, Shandong, China

Site Status RECRUITING

D3 Bio Investigative Site 0301

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

D3 Bio Investigative Site 0308

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

D3 Bio Investigative Site 0316

Chengdu, Sichuan, China

Site Status RECRUITING

D3 Bio Investigative Site 0311

Hangzhou, Zhejiang, China

Site Status RECRUITING

D3 Bio Investigative Site 0315

Changsha, , China

Site Status RECRUITING

D3 Bio Investigative Site 0314

Hefei, , China

Site Status RECRUITING

D3 Bio Investigative Site 0313

Zhengzhou, , China

Site Status RECRUITING

D3 Bio Investigative Site 0804

Bordeaux, , France

Site Status RECRUITING

D3 Bio Investigative Site 0803

Lyon, , France

Site Status RECRUITING

D3 Bio Investigative Site 0801

Rennes, , France

Site Status RECRUITING

D3 Bio Investigative Site 0802

Villejuif, , France

Site Status RECRUITING

D3 Bio Investigative Site 1002

Hamburg, , Germany

Site Status RECRUITING

D3 Bio Investigative Site 0501

Shatin, , Hong Kong

Site Status RECRUITING

D3 Bio Investigative Site 0905

Candiolo, , Italy

Site Status RECRUITING

D3 Bio Investigative Site 0902

Milan, , Italy

Site Status RECRUITING

D3 Bio Investigative Site 0904

Napoli, , Italy

Site Status RECRUITING

D3 Bio Investigative Site 0901

Rome, , Italy

Site Status RECRUITING

D3 Bio Investigative Site 0903

Siena, , Italy

Site Status RECRUITING

D3 Bio Investigative Site 0601

Kashiwa, , Japan

Site Status RECRUITING

D3 Bio Investigative Site 0602

Tokyo, , Japan

Site Status RECRUITING

D3 Bio Investigative Site 0204

Cheongju-si, North Chungcheong, South Korea

Site Status RECRUITING

D3 Bio Investigative Site 0202

Seoul, , South Korea

Site Status RECRUITING

D3 Bio Investigative Site 0203

Seoul, , South Korea

Site Status RECRUITING

D3 Bio Investigative Site 0201

Seoul, , South Korea

Site Status WITHDRAWN

D3 Bio Investigative Site 0706

Barcelona, , Spain

Site Status RECRUITING

D3 Bio Investigative Site 0701

Barcelona, , Spain

Site Status RECRUITING

D3 Bio Investigative Site 0704

Madrid, , Spain

Site Status RECRUITING

D3 Bio Investigative Site 0705

Madrid, , Spain

Site Status RECRUITING

D3 Bio Investigative Site 0703

Valencia, , Spain

Site Status RECRUITING

D3 Bio Investigative Site 0702

Valencia, , Spain

Site Status RECRUITING

Countries

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United States Australia China France Germany Hong Kong Italy Japan South Korea Spain

Central Contacts

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Medical Director

Role: CONTACT

Phone: +86 21 61635900

Email: [email protected]

References

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Cho BC, Lu S, Lee MA, Song Z, Park JJ, Lim SM, Li Z, Zhao J, Richardson G, Zhang Y, Zhang J, Liu A, Loong HH, Chen C, Wang J, Shen Y, Fan Z, Chen Q, Wang H, Zhang J, Chen ZJ, Johnson ML, Mok T. D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial. Nat Med. 2025 Aug;31(8):2768-2777. doi: 10.1038/s41591-025-03688-6. Epub 2025 Apr 29.

Reference Type DERIVED
PMID: 40301557 (View on PubMed)

Other Identifiers

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2023-508517-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D3S-001-100

Identifier Type: -

Identifier Source: org_study_id