A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Eligibility

Primary outcome measure(s)

• Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events — First 28 days (21 days for AG （3-week cycle）)
  The incidence of DLT events
• Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE) — From the first dose until 30 days after the last dose, assessed up to 24 months
  The incidence and severity of AEs and SAEs，according to NCI CTCAE，v6.0
• Phase II:Objective Response Rate (ORR) — 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
  Assessed by investigators according to RECIST 1.1
• Phase Ib: Number of participants with abnormality in hematology laboratory parameters — up to 24 months
  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
• Phase Ib: Number of participants with abnormality in clinical chemistry laboratory assessments — up to 24 months
  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.
• Phase Ib: Number of participants with abnormality in body temperature — up to 24 months
  Number of participants with abnormality in body temperature(°C), throughout the study.
• Phase Ib: Number of participants with abnormality in blood pressure — up to 24 months
  Number of participants with abnormality in blood pressure, including systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
• Phase Ib: Number of participants with abnormality in Physical Examination Findings — up to 24 months
  Number of participants with abnormality in Physical Examination Findings
• Phase Ib: Number of participants with abnormality in PR interval — up to 24 months
  Number of participants with abnormality in electrocardiogram (ECG) parameters, including PR interval
• Phase Ib: Number of participants with abnormality in corrected QT interval using Frederica's formula (QTcF) — up to 24 months
  Number of participants with abnormality incorrected QT interval using Frederica's formula (QTcF)

Trial sites (17)

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