NCT06859762 A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
| NCT ID | NCT06859762 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2025-07-02 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria: * Informed of the study before the start of the study and voluntarily sign their name and date in the ICF * Able and willing to comply with protocol visits and procedures * Age≥ 18 years * ECOG PS of 0 or 1 * Tumor types as below: For Part 1 and Part 2: Pathologically confirmed diagnosis of an advanced solid tumor. For Part 3 (Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease) * Adequate organ and bone marrow function. * Have at least 1 extracranial measurable tumor lesion. * Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy. Exclusion Criteria: * Prior treatment with an agent targeting CDH17 * Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities. * Have received an ADC consisting of a topoisomerase I inhibitor. * Concurrent enrollment in another clinical study, unless it is an observational clinical study. * Inadequate washout period for prior anticancer treatment before the first dose of study drug * Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study. * Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug. * Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study. * Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis. * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases. * A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis. * Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Uncontrolled third-space fluid that requires repeated drainage. * Digestive system disease that may cause bleeding, perforation, jaundice, gastrointestinal obstruction. * An active tuberculosis based on medical history. * Known human immunodeficiency virus (HIV) infection. * Active hepatitis C infection.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06859762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06859762 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06859762 currently recruiting?
Yes, NCT06859762 is actively recruiting participants. Contact the research team at clinicaltrials@medilinkthera.com for enrollment information.
Where is the NCT06859762 trial being conducted?
This trial is being conducted at Phoenix, United States, Santa Monica, United States, New Haven, United States, Kansas City, United States and 11 additional locations.
Who is sponsoring the NCT06859762 clinical trial?
NCT06859762 is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 220 participants.