Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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

NCT ID: NCT06859762Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.Last updated: 2026-01-14

Summary

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Detailed description

YL217 is an antibody-drug conjugate (ADC) that targets CDH17 (Cadherin-17) protein and is being developed for the treatment of cancer. YL217 is comprised of three components: 1) YL217-mAb, a CDH17-targeting recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody, 2) YL0010014, a topoisomerase I inhibitor, and 3) an enzymatically cleavable methylsulfonyl pyrimidine tripeptide drug linker. The in vivo anti-tumor efficacy of YL217 was evaluated in immune-deficient mice bearing human colorectal cancer, gastric cancer and patient derived colorectal cancer xenograft tumors. The results indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in cancer cells or patient derived xenograft models. Therefore, in order to meet the huge unmet medical needs in the field of gastrointestinal cancer treatment, it is planned to conduct the first human phase I clinical study of YL217 in patients with advanced solid tumors.

Arms & interventions

  • DrugYL217

    Patients will be treated with YL217 intravenous(IV)infusion.

  • DrugYL217

    Patients will be treated with YL217 intravenous(IV)infusion.

  • DrugYL217

    Patients will be treated with YL217 intravenous(IV)infusion.

Outcome measures

Primary

  • Nature and frequency of dose-limiting toxicity(DLT)

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

    Time frame: Up to approximately 3 years

  • Nature and frequency of adverse events (AEs) with severity

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

    Time frame: Up to approximately 3 years

  • objective response rate (ORR)

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

    Time frame: Up to approximately 3 years

Secondary

  • Eastern Cooperative Oncology Group performance status (ECOG PS)

    Time frame: Up to approximately 3 years

  • To evaluate safety endpoint of peripheral oxygen saturation (SpO2)

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter AUC

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter Cmax

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter Ctrough

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter Tmax

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter CL

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter Vd

    Time frame: Up to approximately 3 years

  • Characterize Pharmacokinetics(PK) parameter t1/2

    Time frame: Up to approximately 3 years

  • Immunogenicity endpoint: Incidence of anti-YL217 antibody (ADAs).

    Time frame: Up to approximately 3 years

  • Disease control rate (DCR)

    Time frame: Up to approximately 3 years

  • Duration of response (DoR)

    Time frame: Up to approximately 3 years

  • Time to response (TTR)

    Time frame: Up to approximately 3 years

  • Depth of response (DpR)

    Time frame: Up to approximately 3 years

  • Progression-free survival (PFS)

    Time frame: Up to approximately 3 years

  • Overall survival (OS)

    Time frame: Up to approximately 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (13)

Mayo Clinic Arizona

Phoenix, Arizona, 85054

Recruiting
Study Coordinator · Contact

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404

Recruiting
Study Coordinator · Contact

Yale Cancer Center

New Haven, Connecticut, 06519

Recruiting

The University of Kansas Cancer Center (KUCC)

Kansas City, Kansas, 66205

Recruiting
Study Coordinator · Contact

University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical Oncology

Baltimore, Maryland, 21201

Not Yet Recruiting
Study Coordinator · Contact

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Study Coordinator · Contact

Columbia University Irving Medical Center

New York, New York, 10032

Recruiting
Study Coordinator · Contact

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710

Recruiting
Study Coordinator · Contact

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

Recruiting
Study Coordinator · Contact

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195

Recruiting
Study Coordinator · Contact

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Study Coordinator · Contact

UT Health San Antonio - Mays Cancer Center

San Antonio, Texas, 78229

Recruiting
Study Coordinator · Contact

University of Wisconsin Health - UW Carbone Cancer Center

Madison, Wisconsin, 53792

Not Yet Recruiting
Study Coordinator · Contact