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Phase 1 Study of D3S-003 for Advanced KRAS p.G12D Mutant Solid Tumors

This study is testing a new oral tablet called D3S-003 in people with advanced solid tumors that have a specific genetic change called KRAS p.G12D. This is a first-in-human study, meaning it's the first time D3S-003 is being given to people. The main goals are to understand the safety and side effects of D3S-003, find the highest dose that can be given safely, and see if it shows any early signs of helping. You might be able to join if your cancer has progressed after other treatments or if standard treatments aren't suitable. The study plans to enroll 42 participants, but its current recruitment status is unclear.

Study design
This is an open-label, dose-escalation Phase 1 study, meaning everyone knows what treatment is being given. It plans to enroll 42 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events (side effects) from screening until 30 days after their last dose of D3S-003.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07456046

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.

Recruiting
PHASE1Ages 18+InterventionalTreatment
D3 Bio (Wuxi) Co., Ltd
~42 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:D3S-003

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured over From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
+3 more outcomes measured

Conditions

KRAS P.G12D

Explore related trials

Solid NeoplasmGTPase KRas

NCT07456046

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • D3 Bio Investigative Site 1101

    Macquarie Park, New South Wales, Australiano site contact published

    Recruiting

  • D3 Bio Investigative Site 1102

    Malvern, Victoria, Australiano site contact published

    Recruiting

  • D3 Bio Investigative Site 1103

    Randwick, New South Wales, Australiano site contact published

    Recruiting

  • D3 Bio Investigative Site 1201

    Seoul, South Koreano site contact published

    Recruiting

  • D3 Bio Investigative Site 1202

    Seoul, South Koreano site contact published

    Recruiting

  • D3 Bio Investigative Site 1203

    Seoul, South Koreano site contact published

    Recruiting

  • D3 Bio Investigative Site 1402

    San Antonio, Texasno site contact published

    Recruiting

  • D3 Bio Investigative Site 1403

    Houston, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Medical Director
[email protected]
+86 21 61635900
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants with Dose-Limiting Toxicities (DLTs)From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
  • Number of Participants with Adverse Events (AEs)From screening visit until 30 days after the last dose (or specified in the protocol)
  • Maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs)First dose up to 7 months
  • Phase 2 dose (RP2D)First dose up to 7 months