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RecruitingLast updated: 7 March 2025

D3S-001-100: This study is recruiting people with advanced solid cancers with a KRAS p.G12c mutation to determine the recommended dose level, safety and effectiveness of a targeted therapy (called D3S-001)A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

D3S-001-100

Clinical summary

Summary

This study is seeking to understand the appropriate dose level, safety and effectiveness of a new targeted therapy (D3S-001) in people with advanced solid cancers with the Kirsten rat sarcoma viral oncogene homolog gene (KRAS) p.G12C mutation.

 

The study has multiple parts.

In Part 1 (Dose Escalation), all eligible participants will receive D3S-001 alone (as monotherapy), given orally.

In Part 2 (Dose Expansion), participants with certain cancer types will receive D3S-001 as monotherapy, given orally.

Part 3a has multiple arms:

  • Arm A (Dose Expansion), participants with certain cancer types will receive oral D3S-001 in combination with intravenous pembrolizumab immunotherapy.
  • Arm B (Dose Expansion), participants with certain cancer types will receive oral D3S-001 in combination with chemotherapy, either cisplatin + pemetrexed, or carboplatin + pemetrexed. All chemotherapies to be given intravenously.
  • Arm C (Dose Expansion), participants with certain cancer types will receive oral D3S-001 as monotherapy.

In Part 3b, participants with certain cancer types will receive oral D3S-001 in combination with cetuximab targeted therapy, given intravenously.

Conditions

This trial is treating people with solid cancers with KRAS p.G12C mutation

Eligibility

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).

Inclusion

  • 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 (localised).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
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:

  • NCT05410145 *
  • D3 BIO - D3S-001-100 - CT1487; D3S-001-100

Trial sponsor

D3 Bio (Wuxi) Co., Ltd

Scientific Title

A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

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