Clinical Trials in China / NCT07678593
Recruiting
Phase 1/2
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
NCT07678593 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumors CancerPancreatic Ductal AdenocarcinomaRAS Mutation
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
Inclusion Criteria:
1. Age ≥ 18 years
2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification
3. At least one measurable lesion according to RECIST v1.1
4. ECOG performance status 0 or 1
5. Life expectancy \> 3 months
6. Adequate organ function
7. Willing to provide written informed consent
8. Fertile participants must use effective contraception
Exclusion Criteria:
1. Other active malignancy within 3 years
2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
3. History of active clinically significant cardiovascular dysfunction
4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.
5. With active infection (HIV, HBV, HCV, syphilis)
6. The presence of clinical or radiological evidence of intestinal obstruction.
7. Prior anticancer therapy within 28 days or 5 half-lives
8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months
9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.
10. History of central nervous system (CNS)disease
11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.
12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District | Concord | New South Wales | Not Yet Recruiting |
| Macquarie University / Clinical Trials Unit | North Ryde | New South Wales | Recruiting |
| The Queen Elizabeth Hospital | Woodville South | South Australia | Not Yet Recruiting |
| Monash Health (Monash Medical Centre) | Clayton | Victoria | Recruiting |
| Northern Health | Epping | Victoria | Not Yet Recruiting |
| PASO Medical | Frankston | Victoria | Recruiting |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| The Third Affiliated Hospital (Cancer Hospital) of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| The First Affiliated Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Not Yet Recruiting |
| Shandong First Medical University Affiliated Tumor Hospital | Jinan | Shandong | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Recruiting |
| West China Hospital of Sichuan University | Chengdu | Sichuan | Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07678593 on ClinicalTrials.gov ↗ ← All trials in China