A Phase 1/2 interventional study of GFH276 and Cetuximab in Advanced Solid Tumors Cancer, Pancreatic Ductal Adenocarcinoma and RAS Mutation, sponsored by Genfleet Therapeutics (Shanghai) Inc.. Not yet recruiting at 17 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 1/2, Interventional, and Treatment
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
This is an open-label, multicenter Phase Ib/II clinical trial to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of oral GFH276 in combination with cetuximab or standard chemotherapy in adult patients with locally advanced or metastatic RAS-mutated solid tumors and pancreatic ductal adenocarcinoma (PDAC).
Participants will be enrolled into three treatment arms with different combination regimens.
In the Phase Ib stage, dose escalation of GFH276 will be performed in each combination arm to identify the optimal recommended Phase 2 dose (RP2D) based on dose-limiting toxicity (DLT) and the overall safety profile. After RP2D determination, Phase II expansion cohorts will enroll eligible patients to further evaluate the anti-tumor efficacy and long-term safety of each combination regimen. Study-related assessments will include tumor imaging, laboratory tests, adverse event monitoring, and pharmacokinetic sampling throughout the treatment period.
Participants will continue their assigned study treatment until confirmed disease progression, intolerable toxicity, withdrawal of consent, or study closure.
Exclusion Criteria:
GFH276 once daily; cetuximab 500 mg/m² intravenous infusion every 2 weeks.
Drug: GFH276 · Drug: Cetuximab
GFH276 once daily; nab-paclitaxel 125 mg/m² + gemcitabine 1000 mg/m² (AG regimen); 4-week cycle (D1, D8, D15) or 3-week cycle (D1, D8) in China
Drug: GFH276 · Drug: Nab paclitaxel · Drug: Gemcitabine
GFH276 once daily; mFOLFIRINOX :Fluorouracil 2400 mg/m²(46 h), Leucovorin 400 mg/m², Irinotecan 150 mg/m², Oxaliplatin 85 mg/m², IV D1, every 2 weeks . The mFOLFIRINOX regimen may be administered per the above dosage, or in accordance with national or institutional guidelines.
Drug: GFH276 · Drug: Fluorouracil · Drug: Leucovorin · Drug: Irinotecan · Drug: Oxaliplatin
Oral GFH276 administered once daily in combination with other study drugs.
Intravenous cetuximab at a dose of 500 mg/m²
Intravenous nab-paclitaxel at a dose of 125 mg/m².
Intravenous Gemcitabine at a dose of 1000 mg/m².
Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.
Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.
Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.
Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.
Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
The incidence of DLT events
Time frame: First 28 days (21 days for AG （3-week cycle）)
Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
The incidence and severity of AEs and SAEs，according to NCI CTCAE，v6.0
Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months
Phase II:Objective Response Rate (ORR)
Assessed by investigators according to 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
Phase Ib: Number of participants with abnormality in hematology laboratory parameters
Number of participants with abnormality in hematology laboratory parameters，Hematology assessments will include hemoglobin, white blood cell count, differential white blood cell counts and platelet count
Time frame: up to 24 months
Phase Ib: Number of participants with abnormality in clinical chemistry laboratory assessments
Number of participants with abnormality in clinical chemistry laboratory assessments， assessments will include serum chemistry (such as sodium, potassium, urea, creatinine) and liver function parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin.
Time frame: up to 24 months
Phase Ib: Number of participants with abnormality in body temperature
Number of participants with abnormality in body temperature(°C), throughout the study.
Time frame: up to 24 months
Phase Ib: Number of participants with abnormality in blood pressure
Number of participants with abnormality in blood pressure, including systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Time frame: up to 24 months
Phase Ib: Number of participants with abnormality in Physical Examination Findings
Number of participants with abnormality in Physical Examination Findings
Time frame: up to 24 months
Phase Ib: Number of participants with abnormality in PR interval
Number of participants with abnormality in electrocardiogram (ECG) parameters, including PR interval
Time frame: up to 24 months
Phase Ib: Number of participants with abnormality in corrected QT interval using Frederica's formula (QTcF)
Number of participants with abnormality incorrected QT interval using Frederica's formula (QTcF)
Time frame: up to 24 months
Phase II: Incidence and Severity of AE and SAE
Incidence and Severity of AE and SAE，Assessed according to CTCAE 6.0
Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months
DCR
Disease Control Rate (DCR)
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
Duration of Response 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
Time To Response 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 according to RECIST 1.1, as Determined 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
OS
Overall Survival
Time frame: From the first dose until date of death from any cause, assessed up to 24 months
Time to peak plasma concentration（Tmax） of GFH276
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including Tmax were evaluated.
Time frame: up to 6 months
Maximum plasma concentration of GFH276
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including Cmax were evaluated.
Time frame: up to 6 months
Area Under the Curve from time zero to 24 hours of GFH276
Plasma concentrations of GFH276 and relevant pharmacokinetic parameters including AUC0-24 were evaluated.
Time frame: up to 6 months
Plan to share: No
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Genfleet Therapeutics (Shanghai) Inc.