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

March 10, 2026 updated by: D3 Bio (Wuxi) Co., Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

442

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Recruiting
        • D3 Bio Investigative Site 0104
    • New South Wales
      • Sydney, New South Wales, Australia, 2109
        • Recruiting
        • D3 Bio Investigative Site 0102
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • D3 Bio Investigative Site 0101
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • D3 Bio Investigative Site 0105
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • D3 Bio Investigative Site 0103
  • China
      • Changsha, China, 410013
        • Recruiting
        • D3 Bio Investigative Site 0315
      • Hefei, China, 230000
        • Recruiting
        • D3 Bio Investigative Site 0314
      • Zhengzhou, China, 450003
        • Recruiting
        • D3 Bio Investigative Site 0313
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100036
        • Recruiting
        • D3 Bio Investigative Site 0303
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • D3 Bio Investigative Site 0306
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310022
        • Recruiting
        • D3 Bio Investigative Site 0305
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • D3 Bio Investigative Site 0307
    • Hubei
      • Wuhan, Hubei, China, 43000
        • Recruiting
        • D3 Bio Investigative Site 0309
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • D3 Bio Investigative Site 0312
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • Recruiting
        • D3 Bio Investigative Site 0304
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • D3 Bio Investigative Site 0302
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • D3 Bio Investigative Site 0310
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • D3 Bio Investigative Site 0301
      • Shanghai, Shanghai Municipality, China, 201801
        • Recruiting
        • D3 Bio Investigative Site 0308
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • D3 Bio Investigative Site 0316
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • D3 Bio Investigative Site 0311
  • France
      • Bordeaux, France, 33000
        • Recruiting
        • D3 Bio Investigative Site 0804
      • Lyon, France, 69373
        • Recruiting
        • D3 Bio Investigative Site 0803
      • Rennes, France, 35033
        • Recruiting
        • D3 Bio Investigative Site 0801
      • Villejuif, France, 94805
        • Recruiting
        • D3 Bio Investigative Site 0802
  • Germany
      • Hamburg, Germany, 20249
        • Recruiting
        • D3 Bio Investigative Site 1002
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 45147
        • Recruiting
        • D3 Bio Investigative Site 1003
  • Hong Kong
      • Shatin, Hong Kong, 999077
        • Recruiting
        • D3 Bio Investigative Site 0501
  • Italy
      • Candiolo, Italy, 10060
        • Recruiting
        • D3 Bio Investigative Site 0905
      • Milan, Italy, 20141
        • Recruiting
        • D3 Bio Investigative Site 0902
      • Napoli, Italy, 80131
        • Recruiting
        • D3 Bio Investigative Site 0904
      • Rome, Italy, 00144
        • Recruiting
        • D3 Bio Investigative Site 0901
      • Siena, Italy, 53100
        • Recruiting
        • D3 Bio Investigative Site 0903
  • Japan
      • Kashiwa, Japan, 277-8577
        • Recruiting
        • D3 Bio Investigative Site 0601
      • Tokyo, Japan, 104-0045
        • Recruiting
        • D3 Bio Investigative Site 0602
  • South Korea
      • Seoul, South Korea, 06591
        • Recruiting
        • D3 Bio Investigative Site 0202
      • Seoul, South Korea, 120-752
        • Recruiting
        • D3 Bio Investigative Site 0203
      • Seoul, South Korea, 138-736
        • Withdrawn
        • D3 Bio Investigative Site 0201
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Recruiting
        • D3 Bio Investigative Site 0204
  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • D3 Bio Investigative Site 0706
      • Barcelona, Spain, 08035
        • Recruiting
        • D3 Bio Investigative Site 0701
      • Madrid, Spain, 28046
        • Recruiting
        • D3 Bio Investigative Site 0704
      • Madrid, Spain, 28050
        • Recruiting
        • D3 Bio Investigative Site 0705
      • Valencia, Spain, 46010
        • Recruiting
        • D3 Bio Investigative Site 0703
      • Valencia, Spain, 46026
        • Recruiting
        • D3 Bio Investigative Site 0702
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • D3 Bio Investigative Site 0402
      • Palo Alto, California, United States, 94304-2205
        • Recruiting
        • D3 Bio Investigative Site 0407
    • Colorado
      • Denver, Colorado, United States, 80218-1238
        • Recruiting
        • D3 Bio Investigative Site 0404
    • Florida
      • Sarasota, Florida, United States, 34232-6410
        • Recruiting
        • D3 Bio Investigative Site 0406
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Recruiting
        • D3 Bio Investigative Site 0401
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • D3 Bio Investigative Site 0405
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • D3 Bio Investigative Site 0403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Pembrolizumab
Intravenous
Drug: D3S-001
Oral
Experimental: D3S-001 and Cetuximab

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

Cetuximab administered intravenously.
Drug: Cetuximab
Intravenous
Drug: D3S-001
Oral
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.
Drug: D3S-001
Oral
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
Drug: Carboplatin
Intravenous
Drug: Cisplatin
Intravenous
Drug: D3S-001
Oral
Drug: Pemetrexed
Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose until 30 days after the last dose (or specified in the protocol).
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.
From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
D3S-001 maximum observed plasma concentration (Cmax)
Time Frame: Up to 24 months.
Up to 24 months.
D3S-001 time to maximum plasma concentration (tmax)
Time Frame: Up to 24 months.
Up to 24 months.
D3S-001 half-life (t1/2)
Time Frame: Up to 24 months.
Up to 24 months.
D3S-001 area under the concentration-time curve (AUC)
Time Frame: Up to 24 months.
Up to 24 months.
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame: Up to 24 months.
Up to 24 months.
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame: Up to 24 months.
Up to 24 months.
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame: Up to 24 months.
Up to 24 months.
Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame: Up to 24 months.
Up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D3 Bio (Wuxi) Co., Ltd

Investigators

  • Study Director: Cheng Chen, MD, D3 Bio (Wuxi) Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3S-001-100
  • 2023-508517-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on KRAS P.G12C

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe