Study Of JYP0015 In Patients With Advanced Solid Tumors Harboring Specific Mutations In RAS

Study Overview

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

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

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.

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

DRUG: JYP0015

JYP0015M101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-17
First Submitted that Met QC Criteria 2025-03-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-20
First Posted (ACTUAL) 2025-03-26	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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, 6	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-es

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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, 6

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-es

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Maximum Observed Blood Concentration (Cmax) of JYP0015	Maximum plasma concentration (Cmax) of JYP0015 following administration.	Up to 16 weeks
Time to Reach Maximum Blood Concentration (Tmax) of JYP0015	Time to reach maximum plasma concentration (Tmax) of JYP0015 following administration.	Up to 16 weeks
Duration of Response (DOR)	Duration of response as assessed by RECIST v1.1.	Up to 3 years
Time to Response (TTR)	Time to response as assessed by RECIST v1.1.	Up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ling Shen, M.D.

Phone Number: 01088121122

Email: linshenpku@163.com

Study Contact Backup

Name: Xiao

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record