Status:
RECRUITING
Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Lead Sponsor:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Solid Tumor
Pancreatic Ductal Adenocarcinoma (PDAC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Detailed Description
This is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of JYP0015 in adult patients with advanced solid tumors h...
Eligibility Criteria
Inclusion
- Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
- Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
- Adequate organ function
Exclusion
- Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
- Gastrointestinal (GI) disorders that may interfere with drug administration/absorption, including but not limited to: Dysphagia or inability to swallow tablets， Malabsorption syndrome，Refractory nausea, vomiting, or diarrhea，Chronic GI diseases (e.g., Crohn's disease, ulcerative colitis)
- Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \<50%.
- Any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: Alcohol or substance abuse，Concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment)， Familial or social circumstances that may affect patient safety, compliance, or study data collection.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06895031
Start Date
March 31 2025
End Date
December 31 2026
Last Update
July 20 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142