Phase 1 Study of D3S-001 as Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation

JRCT ID: jRCT2031220703

Registered date:14/03/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 14/03/2023
• Target sample size: 10
• Countries of recruitment: US,Japan,Korea,Japan,China,Japan,Australia,Japan,Hong Kong,Japan
• Study type: Interventional
• Intervention(s): D3S-001 administered orally once daily or twice daily

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.

Exclude criteria

- 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).

Related Information

• Primary Sponsor: Kanemitsu Jun
• Secondary ID(s): NCT05410145