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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
* Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy
* 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, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug.
* 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, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease.
* An active tuberculosis based on medical history.
* Known human immunodeficiency virus (HIV) infection.
* Active hepatitis C infection.

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• UCLA Hematology/Oncology - Santa Monica
  Santa Monica, California, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• The University of Kansas Cancer Center (KUCC)
  Kansas City, Kansas, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Angie Cao, MD
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 0512-62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.