A Clinical Study of YL205 in Patients With Advanced Solid Tumors

December 21, 2025 updated by: MediLink Therapeutics (Suzhou) Co., Ltd.

A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 2
  • 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 Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Chongqing, China
      • Chongqing, China
      • Chongqing, China
        • Recruiting
        • Chinese People's Liberation Army Army Characterstic Medical Center
        • Contact:
      • Shanghai, China
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital，Sun Yat-sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Hainan
      • Haikou, Hainan, China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Anyang, Henan, China
      • Zhengzhou, Henan, China
    • Hubei
      • Jingzhou, Hubei, China
        • Recruiting
        • Jingzhou First People's Hospital
        • Contact:
      • Wuhan, Hubei, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Medical College of Hust Tongji Hospital
        • Contact:
      • Wuhan, Hubei, China
        • Recruiting
        • Union hospital Tongji Medical Colllege Huazhong University of School and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Provincial Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
      • Shenyang, Liaoning, China
        • Recruiting
        • The People's Hospital of Liaoning Province
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China
      • Jinan, Shandong, China
        • Recruiting
        • Central Hospital Affiliated to Shandong First Medical University
        • Contact:
      • Linyi, Shandong, China
    • Shanxi
      • Taiyuan, Shanxi, China
      • Xi’an, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Second University Hospital, Sichuan University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital. Zhejiang University School of Medicine
        • Contact:
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute (SCRI)- Denver
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Recruiting
        • Florida Cancer Specialists - Lake Mary
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40241
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Center for advanced Medicine
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center (Oklahoma)
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute - Franz Clinic
        • Contact:
    • Texas
      • Nashville, Texas, United States, 37203
        • Recruiting
        • Sarah Cannon Research (SCRI)-Tennessee
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98915

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:

  • 1) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).

    2) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female subjects.

    5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressing tumors。 6) Patients with positive Napi2b test results at the central laboratory. 9) At least one radiologically evaluable lesion for subjects in Part 1; At least one measurable extracranial lesion (non-radiation fields) for subjects in Part 2 and Part 3.

    10) Expected survival ≥3 months. 11) Female subjects of childbearing potential must agree to take effective contraceptive measures and must not undergo egg donation or egg retrieval for their own use from screening throughout the study period and for at least 6 months after the last dose of the investigational drug. Male subjects must agree to take effective contraceptive measures and must not undergo sperm cryopreservation or sperm donation from screening throughout the study period and for at least 6 months after the last dose of the investigational drug.

    12) subjects must provide tumor samples. 13) Subjects who are capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Exclusion Criteria:

  • 1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.

    3) Subjects who are participating in another clinical study, with the exception an of observational (non-interventional) clinical study or the follow-up period of an interventional study.

    4) Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.

    5) Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.

    6) Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.

    7) Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.

    8) Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.

    9) Subjects who received any live vaccine within 4 weeks prior to the first dose or those who plan to receive live vaccines during the study.

    10) Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.

    11) Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.

    13) Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.

    15) Subjects with medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer, colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage or perforation in the opinion of the investigator.

    16) Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.

    17) Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and a positive titer result.

    18) Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20) Subjects with a history of serious allergic reactions to drugs, inactive ingredients in drug products, or other monoclonal antibodies.

    21) Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.

    22) Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.

    23) Subjects with multiple primary malignancies within 5 years prior to the signing of the ICF, except for fully resected non-melanoma skin cancer, radically treated carcinoma in situ, or other radically treated solid tumors.

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ia: Dose escalation portion
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at several dose levels.
Drug: intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Experimental: Phase Ib: Dose expansion portion
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at no less than two dose levels.
Drug: intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Experimental: Phase II: Cohort expansion portion
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at RP2D.
Drug: intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evalue the DLTs
Time Frame: Approximately within 36 months
Approximately within 36 months
To evalue the TEAEs
Time Frame: Approximately within 36 months
Treatment Emergent Adverse Event
Approximately within 36 months
To evalue the TRAEs
Time Frame: Approximately within 36 months
Treatment Related Adverse Event
Approximately within 36 months
To evalue the serious adverse events (SAEs)
Time Frame: Approximately within 36 months
Approximately within 36 months
Determination of the MTD of YL205 in the pivotal clinical study
Time Frame: Approximately within 36 months
Approximately within 36 months
Determination of the RED of YL205 in the pivotal clinical study
Time Frame: Approximately within 36 months
Approximately within 36 months
Determination of the RP2D of YL205 in the pivotal clinical study
Time Frame: Approximately within 36 months
Approximately within 36 months
Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize the PK parameter Vd
Time Frame: Approximately within 36 months
volume of distribution (Vd)
Approximately within 36 months
Characterize the PK parameter t1/2
Time Frame: Approximately within 36 months
half-life (t1/2)
Approximately within 36 months
Characterize the PK parameter AUC
Time Frame: Approximately within 36 months
area under curve (AUC)
Approximately within 36 months
Characterize the PK parameter Cmax
Time Frame: Approximately within 36 months
maximum concentration (Cmax)
Approximately within 36 months
Characterize the PK parameter Ctrough
Time Frame: Approximately within 36 months
minimum concentration at trough (Ctrough)
Approximately within 36 months
Characterize the PK parameter CL
Time Frame: Approximately within 36 months
plasma clearance (CL)
Approximately within 36 months
Characterize the PK parameter Tmax
Time Frame: Approximately within 36 months
time to maximum concentration (Tmax)
Approximately within 36 months
Assessed the disease control rate (DCR) per RECIST v1.1
Time Frame: Approximately within 36 months
(defined as the proportion of CR, PR, or stable disease (SD))
Approximately within 36 months
Assessed the duration of response (DOR) per RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
Assessed the time to response (TTR) per RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
Assessed the progression free survival (PFS) per RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
Assessed the depth of response (DpR) per RECIST v1.1
Time Frame: Approximately within 36 months
the percentage change in target lesion size
Approximately within 36 months
Assessed the overall survival (OS) per RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
Evaluate the corelaton between different levels of Napi2B expression and the sum of CR rate, PR rate and SD rate
Time Frame: Approximately within 36 months
Approximately within 36 months

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)

June 4, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL205-CN-101-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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