Recruiting
Phase 1

YL217

Sponsor:

MediLink Therapeutics (Suzhou) Co., Ltd.

Code:

NCT06859762

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

YL217

YL217

YL217

Study Details

Brief summary:

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

Conditions

Advanced Solid Tumor

Study ID

NCT06859762

Start date

Jul 2, 2025

Status verified date

Jan, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

experimental: Part 1: Dose-Escalation Part

Participants will receive escalating doses of YL217 until doses for optimization are determined

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.

Interventions

YL217

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

YL217

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

YL217

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

Primary outcome measure

  • Nature and frequency of dose-limiting toxicity(DLT) [ Time Frame: Up to approximately 3 years ]
  • Nature and frequency of adverse events (AEs) with severity [ Time Frame: Up to approximately 3 years ]
  • objective response rate (ORR) [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Angie Cao, MD

+86 0512-62858368clinicaltrials@medilinkthera.com

Locations

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

UCLA Hematology/Oncology - Santa Monica

Recruiting

Santa Monica, California, United States, 90404

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06519

The University of Kansas Cancer Center (KUCC)

Recruiting

Kansas City, Kansas, United States, 66205

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Duke University Medical Center (DUMC)

Recruiting

Durham, North Carolina, United States, 27710

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Cleveland Clinic Taussig Cancer Institute

Recruiting

Cleveland, Ohio, United States, 44195

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

UT Health San Antonio - Mays Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MediLink Therapeutics (Suzhou) Co., Ltd. on 2026-01-14.