Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JYP0015.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 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.
Interventions
- 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.
Primary outcome measures
- Number of Participants with Dose-Limiting Toxicity (DLT) [Time frame: 21 days]
- Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs [Time frame: Up to 3 years]
- Overall Response Rate (ORR) [Time frame: Up to 3 years]
Secondary outcome measures (4)
- Maximum Observed Blood Concentration (Cmax) of JYP0015 [Time frame: Up to 16 weeks]
- Time to Reach Maximum Blood Concentration (Tmax) of JYP0015 [Time frame: Up to 16 weeks]
- Duration of Response (DOR) [Time frame: Up to 3 years]
- Time to Response (TTR) [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06895031 · JYP0015M101