Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06459973

A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-23

252

Participants Needed

43

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 43 locations

1

Sarah Cannon Research Institute (SCRI)- Denver

Denver, Colorado, United States, 80218

Actively Recruiting

2

Yale Cancer Center

New Haven, Connecticut, United States, 06510

Actively Recruiting

3

Florida Cancer Specialists - Lake Mary

Lake Mary, Florida, United States, 32746

Actively Recruiting

4

Norton Cancer Institute

Louisville, Kentucky, United States, 40241

Actively Recruiting

5

Washington University School of Medicine - Center for advanced Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

6

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, United States, 89169

Actively Recruiting

7

Southwest Women's Oncology

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

8

Stephenson Cancer Center (Oklahoma)

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

9

Providence Cancer Institute - Franz Clinic

Portland, Oregon, United States, 97213

Actively Recruiting

10

Sarah Cannon Research (SCRI)-Tennessee

Nashville, Texas, United States, 37203

Actively Recruiting

11

University of Washington

Seattle, Washington, United States, 98915

Actively Recruiting

12

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

13

Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, China

Actively Recruiting

14

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Actively Recruiting

15

Hainan General Hospital

Haikou, Hainan, China

Actively Recruiting

16

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Actively Recruiting

17

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Actively Recruiting

18

Anyang Cancer Hospital

Anyang, Henan, China

Actively Recruiting

19

Henan Cancer Hospital

Zhengzhou, Henan, China

Actively Recruiting

20

Jingzhou First People's Hospital

Jingzhou, Hubei, China

Actively Recruiting

21

Hubei Cancer Hospital

Wuhan, Hubei, China

Actively Recruiting

22

Tongji Medical College of Hust TongJi Hospital

Wuhan, Hubei, China

Actively Recruiting

23

Union hospital Tongji Medical Colllege Huazhong University of School and Technology

Wuhan, Hubei, China

Actively Recruiting

24

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Actively Recruiting

25

Hunan Provincial Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

26

Xiangya Hospital of Central South University

Changsha, Hunan, China

Actively Recruiting

27

Jilin Provincial Cancer Hospital

Changchun, Jilin, China

Actively Recruiting

28

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Actively Recruiting

29

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

Actively Recruiting

30

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Actively Recruiting

31

Qilu Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

32

Shandong Cancer Hospital

Jinan, Shandong, China

Actively Recruiting

33

Linyi Cancer Hospital

Linyi, Shandong, China

Actively Recruiting

34

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Actively Recruiting

35

The First Affiliated Hospital of XI'AN Jiaotong University

Xi’an, Shanxi, China

Actively Recruiting

36

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

37

Yunnan Cancer Hospital

Kunming, Yunnan, China

Actively Recruiting

38

The First Affiliated Hospital. Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

39

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

40

Chinese People's Liberation Army Army Characterstic Medical Center

Chongqing, China

Actively Recruiting

41

Chongqing Cancer Hospital

Chongqing, China

Actively Recruiting

42

The Southwest Hospital of AMU

Chongqing, China

Actively Recruiting

43

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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