YL217 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called YL217, a potential drug for patients with advanced solid tumors, which are cancers that have spread and are difficult to remove surgically. The trial aims to determine a safe dose and assess its effectiveness. It consists of three parts: dose-finding, further testing, and dose confirmation. Eligible participants are those with an advanced solid tumor that cannot be surgically removed or has spread. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, there is a requirement for an adequate washout period (time without taking certain medications) for prior anticancer treatments before starting the study drug.
Is there any evidence suggesting that YL217 is likely to be safe for humans?
Research has shown that YL217 was well tolerated by patients in earlier studies. YL217, a targeted cancer treatment, can slow tumor growth, with effects increasing at higher doses. Importantly, no severe side effects were reported, suggesting it may be safe for humans. However, as this is an early trial, the primary goal is to determine a safe dose, so the treatment's safety remains under close observation.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about YL217 because it offers a novel approach to treating cancer. Unlike many standard cancer treatments that target cancer cells broadly, YL217 is designed to precisely target specific pathways involved in cancer cell growth. This specificity could potentially lead to fewer side effects and more effective treatment outcomes. Additionally, YL217's ability to be administered at multiple dose levels allows for optimization and personalization of treatment, which is not always possible with existing therapies.
What evidence suggests that YL217 might be an effective treatment for cancer?
Research has shown that YL217 may help treat cancer by slowing tumor growth. In studies, participants generally tolerated the treatment well, and higher doses appeared more effective. In this trial, participants will receive YL217 in different phases: the Dose-Escalation Part to determine optimal doses, the backfill stage to test selected doses, and the Dose-Expansion Part to further support dose selection. YL217 combines an antibody with a drug to more accurately target cancer cells. It is primarily being developed for digestive system cancers, such as those in the colon, pancreas, and stomach. This treatment targets a specific protein linked to these cancers, offering a potentially effective option.14678
Are You a Good Fit for This Trial?
Adults aged 18+ with advanced solid tumors, including certain gastrointestinal cancers, who can sign consent and follow study procedures. They must have at least one measurable tumor lesion, good organ function, and an ECOG performance status of 0 or 1. Those with HIV, recent major surgery, severe lung issues or specific prior treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of YL217 to determine the maximum tolerated dose
Backfill
Participants are enrolled at safe and tolerable dose levels determined in the dose escalation phase
Dose Expansion
Dose optimization is performed in disease-specific cohorts with random assignment to dose regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- YL217
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediLink Therapeutics (Suzhou) Co., Ltd.
Lead Sponsor