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Recruiting Phase 2

Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

NCT06895031 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-03-31
Last updated
2026-03-06

Condition(s) studied

Solid TumorPancreatic Ductal Adenocarcinoma (PDAC)Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)

Investigational drug(s) / intervention(s)

JYP0015

JYP0015: 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.

Study summary

Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests. 2. Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment 3. Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1 4. Adequate organ function Exclusion Criteria: 1. Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable. 2. 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) 3. Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \<50%. 4. 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.

Primary outcome measure(s)

  • Number of Participants with Dose-Limiting Toxicity (DLT) — 21 days
    The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.
  • Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs — Up to 3 years
    The incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including abnormalities in laboratory values and vital signs.
  • Overall Response Rate (ORR) — Up to 3 years
    Overall response rate assessed per RECIST v1.1 criteria.

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
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 NCT06895031 on ClinicalTrials.gov ↗ ← All trials in China