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RECRUITING
NCT05410145
PHASE1/PHASE2

A 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

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

442

Start Date

2022-08-03

Completion Date

2027-04

Last Updated

2026-03-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

D3S-001

Oral

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

Pemetrexed

Intravenous

DRUG

Cetuximab

Intravenous

Locations (52)

D3 Bio Investigative Site 0402

Orange, California, United States

D3 Bio Investigative Site 0407

Palo Alto, California, United States

D3 Bio Investigative Site 0404

Denver, Colorado, United States

D3 Bio Investigative Site 0406

Sarasota, Florida, United States

D3 Bio Investigative Site 0401

Detroit, Michigan, United States

D3 Bio Investigative Site 0405

Nashville, Tennessee, United States

D3 Bio Investigative Site 0403

Houston, Texas, United States

D3 Bio Investigative Site 0102

Sydney, New South Wales, Australia

D3 Bio Investigative Site 0101

Malvern, Victoria, Australia

D3 Bio Investigative Site 0105

Melbourne, Victoria, Australia

D3 Bio Investigative Site 0103

Nedlands, Western Australia, Australia

D3 Bio Investigative Site 0104

Bedford Park, Australia

D3 Bio Investigative Site 0303

Beijing, Beijing Municipality, China

D3 Bio Investigative Site 0306

Guangzhou, Guangdong, China

D3 Bio Investigative Site 0305

Hangzhou, Hangzhou, China

D3 Bio Investigative Site 0307

Harbin, Heilongjiang, China

D3 Bio Investigative Site 0309

Wuhan, Hubei, China

D3 Bio Investigative Site 0312

Wuhan, Hubei, China

D3 Bio Investigative Site 0304

Nanchang, Jiangxi, China

D3 Bio Investigative Site 0302

Shenyang, Liaoning, China

D3 Bio Investigative Site 0310

Jinan, Shandong, China

D3 Bio Investigative Site 0301

Shanghai, Shanghai Municipality, China

D3 Bio Investigative Site 0308

Shanghai, Shanghai Municipality, China

D3 Bio Investigative Site 0316

Chengdu, Sichuan, China

D3 Bio Investigative Site 0311

Hangzhou, Zhejiang, China

D3 Bio Investigative Site 0315

Changsha, China

D3 Bio Investigative Site 0314

Hefei, China

D3 Bio Investigative Site 0313

Zhengzhou, China

D3 Bio Investigative Site 0804

Bordeaux, France

D3 Bio Investigative Site 0803

Lyon, France

D3 Bio Investigative Site 0801

Rennes, France

D3 Bio Investigative Site 0802

Villejuif, France

D3 Bio Investigative Site 1003

Cologne, North Rhine-Westphalia, Germany

D3 Bio Investigative Site 1002

Hamburg, Germany

D3 Bio Investigative Site 0501

Shatin, Hong Kong

D3 Bio Investigative Site 0905

Candiolo, Italy

D3 Bio Investigative Site 0902

Milan, Italy

D3 Bio Investigative Site 0904

Naples, Italy

D3 Bio Investigative Site 0901

Rome, Italy

D3 Bio Investigative Site 0903

Siena, Italy

D3 Bio Investigative Site 0601

Kashiwa, Japan

D3 Bio Investigative Site 0602

Tokyo, Japan

D3 Bio Investigative Site 0204

Cheongju-si, North Chungcheong, South Korea

D3 Bio Investigative Site 0202

Seoul, South Korea

D3 Bio Investigative Site 0203

Seoul, South Korea

D3 Bio Investigative Site 0201

Seoul, South Korea

D3 Bio Investigative Site 0706

Barcelona, Spain

D3 Bio Investigative Site 0701

Barcelona, Spain

D3 Bio Investigative Site 0704

Madrid, Spain

D3 Bio Investigative Site 0705

Madrid, Spain

D3 Bio Investigative Site 0703

Valencia, Spain

D3 Bio Investigative Site 0702

Valencia, Spain