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Treatment for advanced solid tumors with a specific KRAS mutation

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

Phase1; Phase2 Interventional D3 Bio (Wuxi) Co., Ltd · NCT05410145

This study is testing a new oral treatment called D3S-001 for people with advanced solid tumors that have a specific KRAS mutation to see if it works and is safe.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment442 (estimated)
Ages18 Years and up
SexAll
SponsorD3 Bio (Wuxi) Co., Ltd Industry-sponsored
Locations52 sites (Orange, California and 51 other locations)
Trial IDNCT05410145 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of D3S-001, either alone or in combination with other therapies, for patients with advanced solid tumors that have a KRAS p.G12C mutation. It is a first-in-human, multicenter, open-label trial that includes both dose-escalation and dose-expansion phases. Participants will take D3S-001 orally in 21-day treatment cycles, and the study will assess pharmacokinetics, pharmacodynamics, and preliminary efficacy of the treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals with confirmed metastatic or locally advanced solid tumors that are progressing and have a documented KRAS p.G12C mutation.

Not a fit: Patients with uncontrolled intercurrent illnesses or those who have received prior treatments without adequate washout periods may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring the KRAS p.G12C mutation.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be viable and beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Orange, California and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions KRAS P.G12CKRAS p.G12CMutationadvanced solid tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.