Actively Recruiting
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2026-01-14
220
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate YL217, an antibody-drug conjugate targeting the CDH17 protein, in patients with advanced solid tumors. YL217 combines a monoclonal antibody, a topoisomerase I inhibitor, and a special drug linker. Preclinical tests in mice showed that YL217 was well tolerated and slowed tumor growth, supporting its study in humans to address unmet needs in gastrointestinal cancer treatment. Participants will receive intravenous infusions of YL217 in a phase 1 clinical trial divided into three parts dose escalation, backfill stage, and dose expansion. Initially, patients will be enrolled at increasing dose levels to find safe and tolerable doses. After determining the maximum tolerated dose and recommended dose for expansion, the dose-expansion part will further support the selection of the optimal dose for future studies. Throughout the trial, researchers will monitor safety by tracking adverse events and dose-limiting toxicities over approximately three years. They will also assess tumor response rates and various pharmacokinetic parameters. Participants will undergo regular evaluations including tumor measurements, organ function tests, and performance status assessments to understand YL217s effects and safety profile.
CONDITIONS
Brief Title
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent form before starting the study
- Willing and able to follow all study visits and procedures
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- For Parts 1 and 2: Pathologically confirmed advanced solid tumor diagnosis
- For Part 3: Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor
- Adequate organ and bone marrow function
- At least one measurable extracranial tumor lesion
- Availability of adequate archival formalin-fixed paraffin embedded (FFPE) tissue from prior biopsy
You will not qualify if you...
- Previous treatment targeting CDH17
- Prior stopping of a topoisomerase I inhibitor due to treatment-related toxicities
- Previous treatment with an antibody-drug conjugate containing a topoisomerase I inhibitor
- Concurrent participation in another clinical study, except observational studies
- Inadequate washout period from prior anticancer treatments before first dose
- Major surgery within 4 weeks before first dose or planned major surgery during study
- Use of long-term systemic steroids or immunosuppressive therapy within 2 weeks before first dose
- Receipt of any live vaccine within 4 weeks before first dose or planned during study
- Diagnosis or signs of spinal cord compression or leptomeningeal carcinomatosis
- Uncontrolled or significant cardiovascular or cerebrovascular disease
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids, or active ILD/pneumonitis
- Severe pulmonary compromise from other illnesses
- Uncontrolled third-space fluid requiring repeated drainage
- Digestive system diseases causing bleeding, perforation, jaundice, or obstruction
- Active tuberculosis by medical history
- Known HIV infection
- Active hepatitis C infection
Research Team
A
Angie Cao, MD
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