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First-in-human use of YL217 for adults with advanced solid tumors

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

PHASE1 · MediLink Therapeutics (Suzhou) Co., Ltd. · NCT06859762

This Phase 1 test gives a new antibody-drug conjugate called YL217 to see if it is safe and helps adults with advanced solid tumors.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorMediLink Therapeutics (Suzhou) Co., Ltd. (industry)
Locations19 sites (Phoenix, Arizona and 18 other locations)
Trial IDNCT06859762 on ClinicalTrials.gov

What this trial studies

YL217 is an antibody-drug conjugate that combines a CDH17-targeting humanized IgG1 antibody with a topoisomerase I inhibitor payload linked by an enzymatically cleavable peptide linker. This first-in-human, open-label Phase 1 program enrolls adults with advanced solid tumors and includes dose-escalation followed by dose-expansion cohorts to characterize safety, tolerability, pharmacokinetics, recommended phase 2 dose, and preliminary anti-tumor activity. Preclinical xenograft models showed dose-dependent tumor growth suppression and tolerability, supporting human testing. Participants must have adequate organ function, an ECOG performance status of 0–1, at least one measurable extracranial lesion, and available archival tumor tissue.

Who should consider this trial

Good fit: Adults aged 18 or older with pathologically confirmed advanced solid tumors, ECOG 0–1, adequate organ and marrow function, at least one measurable extracranial lesion, and available archival FFPE tissue are the intended candidates.

Not a fit: Patients who previously received CDH17-targeting agents, who discontinued topoisomerase I inhibitors for toxicity, who have received topoisomerase I ADCs, or who have inadequate organ function are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, YL217 could provide a new targeted treatment option that slows tumor growth for patients with advanced solid tumors who have limited standard options.

How similar studies have performed: Other ADCs that deliver topoisomerase I inhibitors have shown clinical activity in some cancers, but CDH17-targeted ADCs are novel and YL217 is being tested in humans for the first time.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.