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

January 12, 2026 updated by: MediLink Therapeutics (Suzhou) Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Bejing
      • Beijing, Bejing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Study Coordinator
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Study Coordinator
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
          • Study Coordinator
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Study Coordinator
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Study Coordinator
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Study Coordinator
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
          • Study Coordinator
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA Hematology/Oncology - Santa Monica
        • Contact:
          • Study Coordinator
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center (KUCC)
        • Contact:
          • Study Coordinator
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical Oncology
        • Contact:
          • Study Coordinator
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
          • Study Coordinator
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Study Coordinator
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center (DUMC)
        • Contact:
          • Study Coordinator
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Study Coordinator
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Taussig Cancer Institute
        • Contact:
          • Study Coordinator
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Study Coordinator
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio - Mays Cancer Center
        • Contact:
          • Study Coordinator
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • University of Wisconsin Health - UW Carbone Cancer Center
        • Contact:
          • Study Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 2: The backfill stage of YL217
Patients will be enrolled at one or more dose levels that do not exceed the dose that is deemed safe and tolerable in dose escalation. Then several dose levels will be selected as the recommended dose for expansion (RDE).
Drug: YL217
Patients will be treated with YL217 intravenous(IV)infusion.
Experimental: Part 1: Dose-Escalation Part
Participants will receive escalating doses of YL217 until doses for optimization are determined
Drug: YL217
Patients will be treated with YL217 intravenous(IV)infusion.
Experimental: Part 3: Dose-Expansion Part
Upon completion of Part 1 and Part 2 with determination of MTD/RDE(s), the dose-expansion part will be conducted to further support the RP2D selection.
Drug: YL217
Patients will be treated with YL217 intravenous(IV)infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nature and frequency of dose-limiting toxicity(DLT)
Time Frame: Up to approximately 3 years
The purpose of DLT is to find maximum tolerated dose (MTD).
Up to approximately 3 years
Nature and frequency of adverse events (AEs) with severity
Time Frame: Up to approximately 3 years
Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.
Up to approximately 3 years
objective response rate (ORR)
Time Frame: 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).
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eastern Cooperative Oncology Group performance status (ECOG PS)
Time Frame: Up to approximately 3 years
Deterioration of Eastern Cooperative Oncology Group performance status (ECOG PS)
Up to approximately 3 years
To evaluate safety endpoint of peripheral oxygen saturation (SpO2)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter AUC
Time Frame: Up to approximately 3 years
The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Cmax
Time Frame: Up to approximately 3 years
Maximum concentration：The highest measured concentration of YL217 in the bloodstream.
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Ctrough
Time Frame: Up to approximately 3 years
Trough concentration
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Tmax
Time Frame: Up to approximately 3 years
Time to maximum observed concentration
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter CL
Time Frame: Up to approximately 3 years
Clearance： defined as the amount of drug removed from the bloodstream by the body per unit of time.
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Vd
Time Frame: Up to approximately 3 years
volume of distribution
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter t1/2
Time Frame: Up to approximately 3 years
Half-life time：defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%.
Up to approximately 3 years
Immunogenicity endpoint: Incidence of anti-YL217 antibody (ADAs).
Time Frame: Up to approximately 3 years
The presence of ADAs in patients treated with YL217 will be assessed to evaluate immunogenicity.
Up to approximately 3 years
Disease control rate (DCR)
Time Frame: Up to approximately 3 years
DCR: defined as the proportion of patients who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD).
Up to approximately 3 years
Duration of response (DoR)
Time Frame: Up to approximately 3 years
DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease (PD).
Up to approximately 3 years
Time to response (TTR)
Time Frame: Up to approximately 3 years
TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).
Up to approximately 3 years
Depth of response (DpR)
Time Frame: Up to approximately 3 years
DpR: defined as the proportion of target lesion shrinkage from baseline to maximum tumor size.
Up to approximately 3 years
Progression-free survival (PFS)
Time Frame: Up to approximately 3 years
PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.
Up to approximately 3 years
Overall survival (OS)
Time Frame: Up to approximately 3 years
OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL217-INT-101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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