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A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Summary
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2026-09
Completion Date
2028-09
Last Updated
2026-07-10
Healthy Volunteers
No
Interventions
GFH276
Oral GFH276 administered once daily in combination with other study drugs.
Cetuximab
Intravenous cetuximab at a dose of 500 mg/m²
Nab paclitaxel
Intravenous nab-paclitaxel at a dose of 125 mg/m².
Gemcitabine
Intravenous Gemcitabine at a dose of 1000 mg/m².
Fluorouracil
Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.
Leucovorin
Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.
Irinotecan
Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.
Oxaliplatin
Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.
Locations (17)
Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District
Concord, New South Wales, Australia
Macquarie University / Clinical Trials Unit
North Ryde, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Health (Monash Medical Centre)
Clayton, Victoria, Australia
Northern Health
Epping, Victoria, Australia
PASO Medical
Frankston, Victoria, Australia
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital (Cancer Hospital) of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China