Trials / Completed
CompletedNCT05756153
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GFH925 | GFH925 tablets administered orally daily. |
| DRUG | Cetuximab | Cetuximab administered intravenously Q2W. |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
- First posted
- 2023-03-06
- Last updated
- 2025-08-12
Locations
21 sites across 3 countries: Greece, Italy, Spain
Source: ClinicalTrials.gov record NCT05756153. Inclusion in this directory is not an endorsement.