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

NCT06895031 | Recruiting Phase 2

• 1 other identifier: JYP0015M101
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

PDAC; NSCLC; CRC

Outcome Measures

Primary Outcomes (3)

• 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.

  21 days

• 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.

  Up to 3 years

• Overall Response Rate (ORR)

  Overall response rate assessed per RECIST v1.1 criteria.

  Up to 3 years

Secondary Outcomes (4)

• Maximum Observed Blood Concentration (Cmax) of JYP0015

  Up to 16 weeks

• Time to Reach Maximum Blood Concentration (Tmax) of JYP0015

  Up to 16 weeks

• Duration of Response (DOR)

  Up to 3 years

• Time to Response (TTR)

  Up to 3 years

Study Arms (1)

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.

Drug: JYP0015

Interventions

JYP0015 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.

JYP0015 in RAS-Mutant Solid Tumors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Ling Shen, M.D.

CONTACT

01088121122; linshenpku@163.com

Xiao

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: None (Open Label)

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: March 31, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)