This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
GFH375 once daily (QD). Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGPhase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events
Time frame: up to 28 days
Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months
Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1
Time frame: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Time frame: up to 6 months
Phase II: Incidence and Severity of AE and SAE
Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months
DCR
DCR assessed by investigators
Time frame: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
TTR
TTR assessed by investigators
Time frame: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
DOR
DoR assessed by investigators
Time frame: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors
Time frame: From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
Overall Survival
Time frame: From the first dose until date of death from any cause, assessed up to 24 months
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