← Back to all trials
Not Yet Recruiting
NCT07678593
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
Conditions: Advanced Solid Tumors Cancer, Pancreatic Ductal Adenocarcinoma, RAS Mutation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 222
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Location: Macquarie University / Clinical Trials Unit North Ryde New South Wales
Summary
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07678593). StuddyBuddy aggregates publicly available trial information.