Trials / Completed
CompletedNCT05005234
A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 334 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase Ia: To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925. Phase Ib: To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors. Phase II: To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GFH925 | Administered as an oral tablet formulation |
Timeline
- Start date
- 2021-09-13
- Primary completion
- 2023-02-20
- Completion
- 2024-12-20
- First posted
- 2021-08-13
- Last updated
- 2025-11-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05005234. Inclusion in this directory is not an endorsement.