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First-in-Human Study of YL217 for Advanced Solid Tumors

This study is testing a new drug called YL217 in people with advanced solid tumors (cancers that have spread). YL217 is an antibody-drug conjugate (ADC), which means it's designed to deliver a powerful cancer-fighting drug directly to cancer cells. Researchers want to see how safe YL217 is, what side effects it might cause, and if it can shrink tumors. This is the first time YL217 is being given to humans. The study aims to enroll 220 participants. To join, you must be at least 18 years old, have an advanced solid tumor, and be able to follow study procedures. The study's success will be measured by how many side effects occur and how many patients' tumors shrink.

Study design
This is a "first-in-human" study, meaning it's the first time this drug is being tested in people. It plans to enroll 220 participants.
What's involved
You would receive YL217 through an intravenous (IV) infusion. You would also need to attend study visits and follow procedures.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor the nature and frequency of side effects and how well the treatment works for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06859762

A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
MediLink Therapeutics (Suzhou) Co., Ltd.
~630 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:YL217Bevacizumab5-FU with leucovorin

At a glance

Recruiting sites
18 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nature and frequency of dose-limiting toxicity(DLT)
Measured over Up to approximately 3 years
+2 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT06859762

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, Chinano site contact published

    Recruiting

  • Cleveland Clinic Taussig Cancer Institute

    Cleveland, Ohiono site contact published

    Recruiting

  • Columbia University Irving Medical Center

    New York, New Yorkno site contact published

    Recruiting

  • Duke University Medical Center (DUMC)

    Durham, North Carolinano site contact published

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, Chinano site contact published

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michiganno site contact published

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizonano site contact published

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Bejing, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Angie Cao, MD
[email protected]
+86 0512-62858368
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Nature and frequency of dose-limiting toxicity(DLT)Up to approximately 3 years

    The purpose of DLT is to find maximum tolerated dose (MTD).

  • Nature and frequency of adverse events (AEs) with severityUp to approximately 3 years

    Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.

  • objective response rate (ORR)Up to approximately 3 years

    ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).