A Study of YL202 in Selected Patients With Advanced Solid Tumors

November 20, 2025 updated by: MediLink Therapeutics (Suzhou) Co., Ltd.

A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

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
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China
        • Not yet recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
      • Beijing, Beijing Municipality, China
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • Beijing Tsinghua Chang Gung Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • Not yet recruiting
        • Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Affiliated Tumor Hospital
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, China
      • Chongqing, Chongqing Municipality, China
    • Fujian
      • Fuzhou, Fujian, China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Meizhou, Guangdong, China
      • Shantou, Guangdong, China
        • Recruiting
        • Shantou University Medical College Tumour Hospital
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China
        • Recruiting
        • Guilin Medical College Second Affiliated Hospital
        • Contact:
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Affiliated Tumour Hospital
        • Contact:
      • Nanning, Guangxi, China
        • Recruiting
        • The People's Hospital of Guangxi
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Luoyang, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital Of Henan University&Technology
        • Contact:
      • Nanyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Nanyang Medical College
        • Contact:
      • Xinxiang, Henan, China
        • Recruiting
        • Xinxiang Medical University No.1 Affiliated Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial Chest Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • He'nan Cancer Hospital South Gate
        • Contact:
    • Hubei
      • Jingzhou, Hubei, China
        • Recruiting
        • The First Peoples Hospital of Jingzhou
        • Contact:
      • Wuhan, Hubei, China
      • Wuhan, Hubei, China
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital Tongji Medical College HuaZhong University of Science Technology
        • Contact:
      • Xiangyang, Hubei, China
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Hu'nan Province Cancer Hospital
        • Contact:
      • Yueyang, Hunan, China
        • Recruiting
        • The Third People's Hospital of Hunan Province
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
      • Xuzhou, Jiangsu, China
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Not yet recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Third Hospital of Nanchang
        • Contact:
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The Affiliated Hospital of NanChang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 215000
        • Recruiting
        • Jilin Provincial Cancer Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China
      • Fushun, Liaoning, China, 530021
        • Not yet recruiting
        • Fukuang General Hospital of Liaoning Health Industry Group
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning cancer Hospital & Institute
        • Contact:
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • The First Hospital of China Medical University Physical Examination Center
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Central Hospital Affiliated to Shandong University
        • Contact:
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Provincial Public Health Clinical Center
        • Contact:
      • Jining, Shandong, China
        • Not yet recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Linyi, Shandong, China
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
      • Weifang, Shandong, China
        • Not yet recruiting
        • Weifang People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huashan Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Ninth People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • The Affiliated Huashan Hospital of Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • The No.10 Peoples Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Not yet recruiting
        • Shanxi Province Cancer Hospital
        • Contact:
      • Xian, Shanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
      • Chengdu, Sichuan, China
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital,Sichuan Universtiy
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Not yet recruiting
        • The Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Zhejiang Province People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Province People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang University Medical College Affiliated No.1 Hospital
        • Contact:
      • Jinhua, Zhejiang, China
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang
        • Contact:

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 aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).
  2. Subjects aged from 18-75 (inclusive) years.
  3. Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..
  4. At least one extracranial measurable lesion according to RECIST 1.1.
  5. Archived or fresh tumor tissue samples can be provided.
  6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  7. The function of organs and bone marrow meets the requirements within 7 days before the first dose.
  8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.
  9. With expected survival ≥ 3 months.
  10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Exclusion Criteria:

  1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
  2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
  3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
  4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
  5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
  6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
  7. Prior treatment with systemic steroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
  8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
  9. With meningeal metastasis or cancerous meningitis.
  10. With brain metastasis or spinal cord compression.
  11. Patients with uncontrolled or clinically significant cardiovascular diseases.
  12. Clinically significant complicated pulmonary disorders.
  13. Patients diagnosed with Gilbert syndrome.
  14. Those with uncontrolled effusion in the third space requiring repeated drainage.
  15. With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.
  16. With serious infection before the first dose.
  17. With known human immunodeficiency virus (HIV) infection.
  18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
  20. Unrelieved toxicity of previous anti-tumor therapy.
  21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
  22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
  23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.

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: Corhort A
YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic NSCLC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Drug: YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Experimental: Corhort B
YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic BC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Drug: YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Experimental: Corhort C
YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic HNSCC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Drug: YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Experimental: Corhort D
YL202 is provided as the lyophilized powder, 200 mg/vial. Other locally advanced cancer patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Drug: YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR assessed according to RECIST v1.1
Time Frame: By the end of trial date, approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
By the end of trial date, approximately within 36 months
Determination of the recommended dose of YL202 in the pivotal clinical study
Time Frame: By the end of trial date, approximately within 36 months
By the end of trial date, approximately within 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) assessed according to RECIST v1.1
Time Frame: approximately within 36 months
approximately within 36 months
Clinical benefit rate (CBR) assessed according to RECIST v1.1
Time Frame: approximately within 36 months
approximately within 36 months
depth of response (DpR) assessed according to RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
disease control rate (DCR) assessed according to RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
duration of response (DOR) assessed according to RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
time to response (TTR) assessed according to RECIST v1.1
Time Frame: Approximately within 36 months
Approximately within 36 months
Evaluate the overall survival (OS)
Time Frame: Approximately within 36 months
Approximately within 36 months
Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment
Time Frame: Approximately within 36 months
Approximately within 36 months
Characterize the PK parameter AUC
Time Frame: Approximately within 36 months
steady-state area under curve (AUC)
Approximately within 36 months
Characterize the PK parameter Cmax
Time Frame: Approximately within 36 months
peak concentration (Cmax)
Approximately within 36 months
Characterize the PK parameter Ctrough
Time Frame: Approximately within 36 months
trough concentration (Ctrough)
Approximately within 36 months
Characterize the PK parameter CL
Time Frame: Approximately within 36 months
clearance (CL)
Approximately within 36 months
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
Incidence of anti-YL202 antibody
Time Frame: approximately within 36 months
approximately within 36 months
Establish a POP PK model for exposure-response relationship analysis
Time Frame: approximately within 36 months
approximately within 36 months
Evaluate the relatonship between different levels of HER3 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)

December 15, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL202-CN-201-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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