Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 2
- Status
- Recruiting
- Start
- 2025-03-31
- End
- 2026-12-31
- Enrollment
- 210
- Sites
- 1
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Detailed description · public domain (ClinicalTrials.gov) · T1
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 harboring specific RAS mutations. The study consists of two parts: * Phase 1 (dose escalation) - Evaluates the safety, tolerability, and pharmacokinetic profile of JYP0015 monotherapy, preliminarily assesses efficacy, and determines the recommended dose (RD) for further evaluation. * Phase 2 (indication expansion) - Explores the therapeutic potential of JYP0015 monotherapy at the RD across four predefined cohorts: 1. Pancreatic ductal adenocarcinoma (PDAC) 2. Non-small cell lung cancer (NSCLC) 3. Colorectal cancer (CRC) 4. Other advanced solid tumors Phase 2 will assess both efficacy and safety within these cohorts. JYP0015 is a potent, orally bioavailable pan-RAS inhibitor that selectively targets the active (ON) form of wild-type and mutant RAS across all three isoforms-HRAS, NRAS, and KRAS.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: 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.
Arm · public domain (ClinicalTrials.gov) · T1
JYP0015 in RAS-Mutant Solid Tumors (experimental): This arm includes participants with histologically or pathologically confirmed advanced solid tumors harboring RAS mutations, identified via molecular testing. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, 61, 117, or 146 (e.g., G12, G13, Q61, K117, or A146). Participants will receive JYP0015 as an oral tablet.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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. Time frame: 21 days.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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. Time frame: Up to 3 years.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Overall Response Rate (ORR). Overall response rate assessed per RECIST v1.1 criteria. Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Maximum Observed Blood Concentration (Cmax) of JYP0015. Time frame: Up to 16 weeks.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Time to Reach Maximum Blood Concentration (Tmax) of JYP0015. Time frame: Up to 16 weeks.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Duration of Response (DOR). Time frame: Up to 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Time to Response (TTR). Time frame: Up to 3 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
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.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 210 participants (estimated).