Clinical Trial: NCT05756153
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Genfleet Therapeutics (Shanghai) Inc. |
| Information Provided By: | Genfleet Therapeutics (Shanghai) Inc. |
| Last Update Posted: | 2025-08-12 |
Study Overview
Brief 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
Official Title
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
Conditions
Advance Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: GFH925
- Drug: Cetuximab
Other Study ID Numbers
- GFH925X0201
Start Date (Actual)
2023-04-25
Primary Completion Date (Actual)
2025-04-30
Study Completion Date (Actual)
2025-04-30
Enrollment (Actual)
47
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Genfleet Therapeutics (Shanghai) Inc. |
| Information Provided By: | Genfleet Therapeutics (Shanghai) Inc. |
| Last Update Posted: | 2025-08-12 |
Study Overview
Brief 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
Official Title
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
Conditions
Advance Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: GFH925
- Drug: Cetuximab
Other Study ID Numbers
- GFH925X0201
Start Date (Actual)
2023-04-25
Primary Completion Date (Actual)
2025-04-30
Study Completion Date (Actual)
2025-04-30
Enrollment (Actual)
47
Study Type
Interventional
Phase
Phase 1, Phase 2