Phase 1/2Recruiting
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc. (Industry)
- Enrolment
- 222 planned
- Conditions
- Advanced Solid Tumors Cancer; Pancreatic Ductal Adenocarcinoma; RAS Mutation
- Interventions
- GFH276; Cetuximab; Nab paclitaxel; Gemcitabine; Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin
- Ages
- adults, older adults
- Registry
- NCT07678593
Full record on ClinicalTrials.gov
From the registry
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
Primary outcomes
- Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
- Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
- Phase II:Objective Response Rate (ORR)
- Phase Ib: Number of participants with abnormality in hematology laboratory parameters
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered