RecruitingPhase 2NCT06895031

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

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


Sponsor

Guangzhou JOYO Pharma Co., Ltd

Enrollment

210 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JYP0015 in people with advanced solid tumors that have a specific genetic change called a RAS mutation. RAS mutations are common drivers of many cancers, and this drug is designed to target them. The goal is to find out if JYP0015 is safe and effective for patients whose cancer has continued to grow despite previous treatments. **You may be eligible if...** - You have a solid tumor (confirmed by biopsy or lab testing) with a RAS mutation - Your cancer has progressed or you could not tolerate prior standard treatments - You are physically well enough to participate (ECOG performance status 0 or 1 — able to carry out normal activities) - Your kidney, liver, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal cord (central nervous system metastases) - You have serious heart, liver, or kidney problems that could make treatment unsafe - You are pregnant or breastfeeding - You have certain other active cancers or conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJYP0015

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.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06895031


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