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New pill targets Hard-to-Treat cancer mutation

NCT ID NCT05410145

Disease control Sponsor: D3 Bio (Wuxi) Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tests a new oral drug called D3S-001, alone or with other cancer drugs, in people with advanced solid tumors that have a specific KRAS G12C mutation. The trial has two phases: first to find the safest dose, then to see if it shrinks tumors. About 442 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
D3S-001 (oral drug)
What this could lead to
If successful, this could provide a new treatment option for people with advanced cancers that have a specific KRAS mutation.
What could go wrong
This is an early-phase trial, so the drug may not work or could cause serious side effects. It is only for people with a specific genetic mutation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 442 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

KRAS P.G12C

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • D3 Bio Investigative Site 0101

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • D3 Bio Investigative Site 0102

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • D3 Bio Investigative Site 0103

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • D3 Bio Investigative Site 0104

    RECRUITING

    Bedford Park, 5042, Australia

  • D3 Bio Investigative Site 0105

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • D3 Bio Investigative Site 0201

    WITHDRAWN

    Seoul, 138-736, South Korea

  • D3 Bio Investigative Site 0202

    RECRUITING

    Seoul, 06591, South Korea

  • D3 Bio Investigative Site 0203

    RECRUITING

    Seoul, 120-752, South Korea

  • D3 Bio Investigative Site 0204

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • D3 Bio Investigative Site 0301

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • D3 Bio Investigative Site 0302

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • D3 Bio Investigative Site 0303

    RECRUITING

    Beijing, Beijing Municipality, 100036, China

  • D3 Bio Investigative Site 0304

    RECRUITING

    Nanchang, Jiangxi, 330008, China

  • D3 Bio Investigative Site 0305

    RECRUITING

    Hangzhou, Hangzhou, 310022, China

  • D3 Bio Investigative Site 0306

    RECRUITING

    Guangzhou, Guangdong, 510120, China

  • D3 Bio Investigative Site 0307

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • D3 Bio Investigative Site 0308

    RECRUITING

    Shanghai, Shanghai Municipality, 201801, China

  • D3 Bio Investigative Site 0309

    RECRUITING

    Wuhan, Hubei, 43000, China

  • D3 Bio Investigative Site 0310

    RECRUITING

    Jinan, Shandong, 250117, China

  • D3 Bio Investigative Site 0311

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • D3 Bio Investigative Site 0312

    RECRUITING

    Wuhan, Hubei, 430079, China

  • D3 Bio Investigative Site 0313

    RECRUITING

    Zhengzhou, Hunan, 450003, China

  • D3 Bio Investigative Site 0314

    RECRUITING

    Hefei, Anhui, 230000, China

  • D3 Bio Investigative Site 0315

    RECRUITING

    Changsha, Hunan, 410013, China

  • D3 Bio Investigative Site 0316

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • D3 Bio Investigative Site 0401

    RECRUITING

    Detroit, Michigan, 48202-2608, United States

  • D3 Bio Investigative Site 0402

    RECRUITING

    Orange, California, 92868, United States

  • D3 Bio Investigative Site 0403

    RECRUITING

    Houston, Texas, 77030, United States

  • D3 Bio Investigative Site 0404

    RECRUITING

    Denver, Colorado, 80218-1238, United States

  • D3 Bio Investigative Site 0405

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • D3 Bio Investigative Site 0406

    RECRUITING

    Sarasota, Florida, 34232-6410, United States

  • D3 Bio Investigative Site 0407

    RECRUITING

    Palo Alto, California, 94304-2205, United States

  • D3 Bio Investigative Site 0501

    RECRUITING

    Shatin, 999077, Hong Kong

  • D3 Bio Investigative Site 0601

    RECRUITING

    Kashiwa, 277-8577, Japan

  • D3 Bio Investigative Site 0602

    RECRUITING

    Tokyo, 104-0045, Japan

  • D3 Bio Investigative Site 0701

    RECRUITING

    Barcelona, 08035, Spain

  • D3 Bio Investigative Site 0702

    RECRUITING

    Valencia, 46026, Spain

  • D3 Bio Investigative Site 0703

    RECRUITING

    Valencia, 46010, Spain

  • D3 Bio Investigative Site 0704

    RECRUITING

    Madrid, 28046, Spain

  • D3 Bio Investigative Site 0705

    RECRUITING

    Madrid, 28050, Spain

  • D3 Bio Investigative Site 0706

    RECRUITING

    Barcelona, 08023, Spain

  • D3 Bio Investigative Site 0801

    RECRUITING

    Rennes, 35033, France

  • D3 Bio Investigative Site 0802

    RECRUITING

    Villejuif, 94805, France

  • D3 Bio Investigative Site 0803

    RECRUITING

    Lyon, 69373, France

  • D3 Bio Investigative Site 0804

    RECRUITING

    Bordeaux, 33000, France

  • D3 Bio Investigative Site 0901

    RECRUITING

    Rome, 00144, Italy

  • D3 Bio Investigative Site 0902

    RECRUITING

    Milan, 20141, Italy

  • D3 Bio Investigative Site 0903

    RECRUITING

    Siena, 53100, Italy

  • D3 Bio Investigative Site 0904

    RECRUITING

    Naples, 80131, Italy

  • D3 Bio Investigative Site 0905

    RECRUITING

    Candiolo, 10060, Italy

  • D3 Bio Investigative Site 1002

    RECRUITING

    Hamburg, 22297, Germany

  • D3 Bio Investigative Site 1003

    RECRUITING

    Cologne, North Rhine-Westphalia, 45147, Germany

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