Actively Recruiting
Pan-RAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors Harboring Mutations in KRAS, HRAS, or NRAS
Led by Shanghai YingLi Pharmaceutical Co. Ltd. · Updated on 2025-04-09
60
Participants Needed
3
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, tolerability, drug levels, pharmacodynamic effects, and clinical activity of YL 17231 in patients with advanced solid tumors harboring mutations in KRAS, HRAS, or NRAS.
CONDITIONS
Official Title
Pan-RAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors Harboring Mutations in KRAS, HRAS, or NRAS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have unresectable or metastatic advanced solid tumors with no standard therapies or progressed on/intolerant to standard therapies
- Have tumors with KRAS, HRAS, or NRAS mutations confirmed by lab testing
- Have measurable disease with at least one lesion suitable for response assessment
- Have adequate organ function as defined by specific blood tests within 7 days before treatment
- Have an ECOG performance status of 0 or 1
- Have a life expectancy of at least 12 weeks
- Women of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Women of childbearing potential must agree to use contraception from 30 days before first dose to 3 months after last dose
- Male patients of childbearing potential must be surgically sterile or agree to use contraception during study and for 3 months after last dose
- Be aged 18 years or older at screening
- Able and willing to provide written informed consent and follow study instructions
- Have completed required washout periods from prior anti-tumor therapies as specified
You will not qualify if you...
- Have symptomatic brain metastases requiring high-dose steroids or recent steroid dose increase within 14 days before first dose
- Receiving any concurrent chemotherapy, immunotherapy, biologic, or hormonal cancer treatments
- Have unresolved toxicities from prior therapies above grade 1 except certain treated conditions
- Have HIV infection with AIDS-defining illness or low CD4 count and high viral load
- Have active viral hepatitis, except with controlled chronic hepatitis B or cured hepatitis C under medical discussion
- Have significant heart conditions within last 6 months including heart failure, arrhythmias, acute coronary syndrome, or ECG abnormalities
- Have prolonged QTc interval above 450 ms or low heart function (LVEF below 50%)
- Have severe or uncontrolled systemic diseases such as uncontrolled hypertension, diabetes, bleeding disorders, or infections
- Have difficulty swallowing pills or gastrointestinal conditions affecting drug absorption
- Have history or current pneumonitis or interstitial lung disease requiring steroids
- Have another active progressing malignancy needing treatment except some skin or cervical cancers
- Have known allergy to any component of YL-17231
- Have psychiatric or substance abuse disorders interfering with study cooperation
- Are pregnant, breastfeeding, or planning pregnancy during the study and 3 months after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Huntsman Cancer Institute and Hospital, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
D
David S. Hong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here