Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JYP0015 in Advanced Solid Tumors With RAS Mutation
Guangzhou JOYO Pharma Co., Ltd
210 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
Summary
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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.
Interventions
JYP0015 is an orally bioavailable pan-RAS inhibitor designed to target the active (ON) form of wild-type and mutant RAS across KRAS, NRAS, and HRAS isoforms. The drug will be administered orally, with dosing determined by the study protocol in the dose-escalation and indication-expansion phases.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06895031