About this trial
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
JYP0015
DrugJYP0015 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Dose-Limiting Toxicity (DLT)
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
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)
Overall response rate assessed per RECIST v1.1 criteria.
Secondary outcomes
Maximum Observed Blood Concentration (Cmax) of JYP0015
Maximum plasma concentration (Cmax) of JYP0015 following administration.
Time to Reach Maximum Blood Concentration (Tmax) of JYP0015
Time to reach maximum plasma concentration (Tmax) of JYP0015 following administration.
Duration of Response (DOR)
Duration of response as assessed by RECIST v1.1.
Time to Response (TTR)
Time to response as assessed by RECIST v1.1.
Sponsors and contacts
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