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NCT05410145PHASE1, PHASE2Recruiting

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

D3 Bio (Wuxi) Co., Ltd

Start Date

8/3/2022

Completion Date

4/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

D3S-001

DRUG

Pembrolizumab

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

Cetuximab

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Conditions

KRAS P.G12C

Locations

D3 Bio Investigative Site 0402

Orange, California 92868

United States

D3 Bio Investigative Site 0407

Palo Alto, California 94304-2205

United States

D3 Bio Investigative Site 0404

Denver, Colorado 80218-1238

United States

D3 Bio Investigative Site 0406

Sarasota, Florida 34232-6410

United States

D3 Bio Investigative Site 0401

Detroit, Michigan 48202-2608

United States

D3 Bio Investigative Site 0405

Nashville, Tennessee 37203

United States

D3 Bio Investigative Site 0403

Houston, Texas 77030

United States

D3 Bio Investigative Site 0102

Sydney, New South Wales 2109

Australia

D3 Bio Investigative Site 0101

Malvern, Victoria 3144

Australia

D3 Bio Investigative Site 0105

Melbourne, Victoria 3000

Australia

D3 Bio Investigative Site 0103

Nedlands, Western Australia 6009

Australia

D3 Bio Investigative Site 0104

Bedford Park, 5042

Australia

D3 Bio Investigative Site 0303

Beijing, Beijing Municipality 100036

China

D3 Bio Investigative Site 0306

Guangzhou, Guangdong 510120

China

D3 Bio Investigative Site 0305

Hangzhou, Hangzhou 310022

China

D3 Bio Investigative Site 0307

Harbin, Heilongjiang 150081

China

D3 Bio Investigative Site 0309

Wuhan, Hubei 43000

China

D3 Bio Investigative Site 0312

Wuhan, Hubei 430079

China

D3 Bio Investigative Site 0304

Nanchang, Jiangxi 330008

China

D3 Bio Investigative Site 0302

Shenyang, Liaoning 110042

China

D3 Bio Investigative Site 0310

Jinan, Shandong 250117

China

D3 Bio Investigative Site 0301

Shanghai, Shanghai Municipality 200030

China

D3 Bio Investigative Site 0308

Shanghai, Shanghai Municipality 201801

China

D3 Bio Investigative Site 0316

Chengdu, Sichuan 610041

China

D3 Bio Investigative Site 0311

Hangzhou, Zhejiang 310003

China

D3 Bio Investigative Site 0315

Changsha, 410013

China

D3 Bio Investigative Site 0314

Hefei, 230000

China

D3 Bio Investigative Site 0313

Zhengzhou, 450003

China

D3 Bio Investigative Site 0804

Bordeaux, 33000

France

D3 Bio Investigative Site 0803

Lyon, 69373

France

D3 Bio Investigative Site 0801

Rennes, 35033

France

D3 Bio Investigative Site 0802

Villejuif, 94805

France

D3 Bio Investigative Site 1003

Cologne, North Rhine-Westphalia 45147

Germany

D3 Bio Investigative Site 1002

Hamburg, 20249

Germany

D3 Bio Investigative Site 0501

Shatin, 999077

Hong Kong

D3 Bio Investigative Site 0905

Candiolo, 10060

Italy

D3 Bio Investigative Site 0902

Milan, 20141

Italy

D3 Bio Investigative Site 0904

Naples, 80131

Italy

D3 Bio Investigative Site 0901

Rome, 00144

Italy

D3 Bio Investigative Site 0903

Siena, 53100

Italy

D3 Bio Investigative Site 0601

Kashiwa, 277-8577

Japan

D3 Bio Investigative Site 0602

Tokyo, 104-0045

Japan

D3 Bio Investigative Site 0204

Cheongju-si, North Chungcheong 28644

South Korea

D3 Bio Investigative Site 0202

Seoul, 06591

South Korea

D3 Bio Investigative Site 0203

Seoul, 120-752

South Korea

D3 Bio Investigative Site 0201

Seoul, 138-736

South Korea

D3 Bio Investigative Site 0706

Barcelona, 08023

Spain

D3 Bio Investigative Site 0701

Barcelona, 08035

Spain

D3 Bio Investigative Site 0704

Madrid, 28046

Spain

D3 Bio Investigative Site 0705

Madrid, 28050

Spain

D3 Bio Investigative Site 0703

Valencia, 46010

Spain

D3 Bio Investigative Site 0702

Valencia, 46026

Spain