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

NCT ID: NCT06895031

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Solid Tumor; Pancreatic Ductal Adenocarcinoma (PDAC); Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JYP0015 in RAS-Mutant Solid Tumors

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.

Group Type: EXPERIMENTAL

JYP0015

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou JOYO Pharma Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ling Shen, M.D.

Role: CONTACT

linshenpku@163.com

01088121122 ext. +86

Xiao

Role: CONTACT

Facility Contacts

Shen Lin, M.D.

Role: primary

linshenpku@163.com

010-88196861 ext. +86

Other Identifiers

JYP0015M101

Identifier Type: -

Identifier Source: org_study_id