Study on D3S 001 Alone or with Other Treatments for Advanced Solid Tumors with a KRAS P.G12C Mutation

Sponsor: D3 Bio (Wuxi) Co., Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05410145

Provider View

This clinical trial is testing a new drug, D3S-001, either by itself or combined with other treatments, to see if it is safe and effective for people with advanced solid tumors that have a specific KRAS mutation.

Patient Parameters

Program Overview

This study is the first time D3S-001 is being tested in humans. It is being conducted at multiple locations and is open to participants. The trial is in Phase 1/2, which means it is looking at how safe and tolerable the drug is, how it behaves in the body, and its early effects on the cancer. Participants will take D3S-001 by mouth every day in 21-day cycles to see how well it works against tumors with the KRAS p.G12C mutation.

Eligibility 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

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