臨床研究等提出・公開システム

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 (D3S-001-100)

A Phase 1/2 Study of D3S-001 as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation (D3S-001-100)

Chen Cheng

D3 Bio (Wuxi) Co., Ltd

Room 324, 88 MeiLiang Road, MaShan, BinHu District, Wuxi, JiangSu, China

D3bio_CT@d3bio.com

Contact for clinical trial information

Fortrea Japan K.K.

Harumi Triton Square Office Tower Y 8F 1-8-11, Harumi, Chuo-ku,Tokyo

+81-3-6837-9500

D3-Bio_D3S-001-100_Japan@fortrea.com

Recruiting

Mar. 14, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

- 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).

Both

Advanced Solid Tumors

D3S-001 administered orally once daily or twice daily

- Number of Participants With Adverse Events (AEs)
- Number of Participants With Dose-Limiting Toxicities (DLTs)

+81-3-3542-2511

June. 27, 2025

No

US/Korea/China/Australia/Hong Kong/France/Germay/Italy/Spain