YL-17231 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, YL-17231, to determine its safety and effectiveness for people with advanced solid tumors that have specific gene mutations (KRAS, HRAS, or NRAS). Researchers aim to find the optimal dose and gather information on the drug's behavior in the body. It suits those whose cancer has not responded to standard treatments and who have measurable disease that can be tracked. Participants should have faced their condition without any successful therapy options available. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there is a required 'washout period' (time without taking certain medications) for prior anti-tumor therapies, which varies depending on the type of therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that YL-17231 is likely to be safe for humans?
Research shows that YL-17231 remains under study, and detailed safety information is limited. In its early trial phase, researchers are determining its safety for people. This phase typically involves testing various doses to identify the maximum amount people can take without serious side effects.
Since YL-17231 is not yet approved for any condition, no existing safety record is available. The current focus is on understanding its tolerability and potential side effects. Participants in this study contribute to gathering this crucial information.12345Why do researchers think this study treatment might be promising?
Researchers are excited about YL-17231 because it offers a new approach to treating solid tumors. Unlike many standard treatments that target specific proteins or pathways, YL-17231 may have a novel mechanism of action that could potentially enhance its effectiveness compared to existing therapies like chemotherapy or targeted drugs. Additionally, the dose escalation phase is designed to determine the maximum tolerated dose, which could optimize its safety profile and effectiveness. Overall, YL-17231 holds promise for providing a new therapeutic option that differs from current treatments by possibly improving safety and efficacy in managing solid tumors.
What evidence suggests that YL-17231 might be an effective treatment for solid tumors?
Research shows that YL-17231 could be a promising treatment for advanced solid tumors with specific changes in the KRAS, HRAS, or NRAS genes. These genetic changes often promote cancer growth, and YL-17231 blocks these genes from doing so. Early findings suggest that YL-17231 disrupts the cancer cells' ability to communicate and multiply. In this trial, participants will receive YL-17231 in a dose escalation and expansion study to determine the maximum tolerated dose and gather early evidence of clinical activity. Initial studies focus on understanding the drug's efficacy and safety, but its mechanism provides a strong basis for its potential effectiveness. Although clinical data are still being collected, the treatment targets a key cancer pathway, which could significantly slow tumor growth.12345
Are You a Good Fit for This Trial?
Adults (≥18 years) with advanced solid tumors that have specific mutations in KRAS, HRAS, or NRAS genes and no standard treatment options left. They should be able to swallow pills, not have active infections or other cancers needing treatment, and must not be pregnant or breastfeeding. Participants need a life expectancy of at least 12 weeks, good performance status (able to carry out daily activities), adequate organ function, and acceptable blood counts.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase Ia)
3+3 design dose escalation study to evaluate safety, tolerability, and determine the MTD and/or RP2D of YL-17231
Dose Expansion (Phase Ib)
Dose expansion phase to further evaluate safety, tolerability, and preliminary anti-tumor activity at the RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- YL-17231
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai YingLi Pharmaceutical Co. Ltd.
Lead Sponsor