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New pill targets Hard-to-Treat cancer mutation in early human test

NCT ID NCT07456046

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 09, 2026 · Updated 7 times

Summary

This early-stage trial is testing an experimental oral drug called D3S-003 in 42 people with advanced solid tumors that have a specific genetic change called KRAS G12D. The main goals are to check the drug's safety, find the right dose, and see how the body processes it. Participants must have already tried standard treatments without success.

What this could mean

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

Active substance
D3S-003 (an oral tablet targeting KRAS G12D mutations)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced cancers that have a specific KRAS mutation.
What could go wrong
This is a very early, small Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not shrink tumors or could cause side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

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

Started

May 2026

Expected to finish

Jan 2028

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 Criteria: * Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has failed to respond to adequate standard treatment(s), or for which no effective standard treatment is available. * Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years. * Subjects 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 Criteria: * Participant has any prior treatment with a specific KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader. * Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent. * Uncontrolled or untreated brain metastases * Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy NOTE: 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.G12D

How to take part

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

  1. The places running it

    9 sites in 3 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 1101

    RECRUITING

    Macquarie Park, New South Wales, 2109, Australia

  • D3 Bio Investigative Site 1102

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • D3 Bio Investigative Site 1103

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • D3 Bio Investigative Site 1201

    RECRUITING

    Seoul, 03080, South Korea

  • D3 Bio Investigative Site 1202

    RECRUITING

    Seoul, 06591, South Korea

  • D3 Bio Investigative Site 1203

    RECRUITING

    Seoul, 03722, South Korea

  • D3 Bio Investigative Site 1402

    RECRUITING

    San Antonio, Texas, 78229, United States

  • D3 Bio Investigative Site 1403

    RECRUITING

    Houston, Texas, 77030, United States

  • D3 Bio Investigative Site 1404

    RECRUITING

    New Haven, Connecticut, 06511, United States