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RecruitingLast updated: 13 August 2026

D3S-003-100: Evaluating a new targeted treatment for people with advanced, recurrent or metastatic solid cancers with a KRAS G12D mutationA Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

D3S-003-100

Clinical summary

Summary

This is an early phase (Phase 1) clinical trial testing a new targeted cancer treatment called D3S-003. 
 
D3S-003 is an investigational targeted therapy designed to treat cancers with a KRAS G12D mutation. KRAS mutations can help cancer cells grow and survive. Researchers hope that targeting this mutation may slow or stop tumour growth.

The main aim of the study is to find out:

  • How safe D3S-003 is
  • What side effects it may cause
  • How the body processes the drug
  • Whether the drug shows signs of helping control cancer growth

Who can take part?
You may be eligible for this study if:

  • You are aged 18 years or older
  • You have a solid tumour that is locally advanced, recurrent, or metastatic
  • Your cancer has worsened after at least one standard treatment, or standard treatment is no longer suitable for you
  • Testing has shown your cancer has a KRAS G12D mutation

What does participation involve?
Participants will receive D3S-003, which is taken by mouth as a tablet. Participants will be monitored by the study team during treatment.

Conditions

This trial is treating people with locally advanced, recurrent or metastatic cancer that has progressed after at least one line of prior treatment

Eligibility

Inclusion

  • Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has progressed following at least one line of standard therapy or where standard therapy has proven to be ineffective or intolerable or is considered inappropriate or when participation in a clinical trial of an investigational agent is considered a standard therapeutic option.
  • 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

NOTE: Other protocol inclusion/exclusion criteria may apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

D3 Bio (Wuxi) Co., Ltd

Scientific Title

A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation

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