A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Last updated: December 21, 2025
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

intravenous (IV) infusion

Clinical Study ID

NCT06459973
YL205-CN-101-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Subjects who are informed of relevant information of the study prior toinitiation of the study and voluntarily sign and date on the informed consent form (ICF).
  1. Age ≥18 years. 3) Be willing to follow and be able to complete all the studyprocedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and bodyweight ≥45kg for female subjects.

5) Patients with histologically or cytologically confirmed locally advanced ormetastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC),renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressingtumors。 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 onemeasurable extracranial lesion (non-radiation fields) for subjects in Part 2 andPart 3.

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

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

Exclusion

Exclusion Criteria:

    1. Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with ahistory of intolerance to topoisomerase I inhibitors or ADC therapy.
  1. Subjects who are participating in another clinical study, with the exception anof observational (non-interventional) clinical study or the follow-up period of aninterventional study.

  2. Subjects with an insufficient washout period from the previous anti-tumor therapyto the first dose.

  3. Subjects who received radiotherapy, including palliative stereotacticradiotherapy on the abdomen, within 4 weeks prior to the first dose.

  4. Subjects who received major surgery within 4 weeks prior to the first dose orthose who plan to receive major surgery during the study.

  5. Subjects who received allogeneic bone marrow transplantation or solid organtransplantation.

  6. Subjects who received systemic steroids or other immunosuppressive treatmentwithin 2 weeks prior to the first dose of the investigational drug.

  7. Subjects who received any live vaccine within 4 weeks prior to the first dose orthose who plan to receive live vaccines during the study.

  8. Subjects with a medical history of leptomeningeal carcinoma or cancerousmeningitis.

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

  10. Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects withsignificantly symptomatic or unstable effusion in the third space requiring repeateddrainage.

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

  12. Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to thefirst dose.

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

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

  15. Female subjects who are pregnant as confirmed by a pregnancy test within 3 daysprior to the first dose, or lactating women.

  16. Subjects who have any diseases, medical conditions, organ system dysfunction, orsocial conditions.

  17. Subjects with multiple primary malignancies within 5 years prior to the signingof the ICF, except for fully resected non-melanoma skin cancer, radically treatedcarcinoma in situ, or other radically treated solid tumors.

Study Design

Total Participants: 252
Treatment Group(s): 1
Primary Treatment: intravenous (IV) infusion
Phase: 1/2
Study Start date:
June 04, 2024
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Fujian Provincial Cancer Hospital

    Fuzhou 1810821, Fujian 1811017
    China

    Active - Recruiting

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

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning 1799869, Guangxi 1809867
    China

    Active - Recruiting

  • Hainan General Hospital

    Haikou 1809078, Hainan 1809054
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965
    China

    Active - Recruiting

  • Anyang Cancer Hospital

    Anyang 1785294, Henan 1808520
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520
    China

    Active - Recruiting

  • Jingzhou First People's Hospital

    Jingzhou 1805540, Hubei 1806949
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Tongji Medical College of Hust TongJi Hospital

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Union hospital Tongji Medical Colllege Huazhong University of School and Technology

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Hunan Provincial Cancer Hospital

    Changsha 1815577, Hunan 1806691
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691
    China

    Active - Recruiting

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin
    China

    Site Not Available

  • Jilin Provincial Cancer Hospital

    Changchun 2038180, Jilin 2036500
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang 2034937, Liaoning 2036115
    China

    Active - Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang 2034937, Liaoning 2036115
    China

    Active - Recruiting

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan 1805753, Shandong 1796328
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan 1805753, Shandong 1796328
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi 1803318, Shandong 1796328
    China

    Active - Recruiting

  • Shanxi Cancer Hospital

    Taiyuan 1793511, Shanxi 1795912
    China

    Active - Recruiting

  • The First Affiliated Hospital of XI'AN Jiaotong University

    Xi’an 11474004, Shanxi 1795912
    China

    Active - Recruiting

  • West China Second University Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming 1804651, Yunnan 1785694
    China

    Active - Recruiting

  • The First Affiliated Hospital. Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670,
    China

    Active - Recruiting

  • Chinese People's Liberation Army Army Characterstic Medical Center

    Chongqing 1814906,
    China

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing 1814906,
    China

    Active - Recruiting

  • The Southwest Hospital of AMU

    Chongqing 1814906,
    China

    Active - Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai 1796236,
    China

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI)- Denver

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Lake Mary

    Lake Mary 4161373, Florida 4155751 32746
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Active - Recruiting

  • Washington University School of Medicine - Center for advanced Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

    Las Vegas 5506956, Nevada 5509151 89169
    United States

    Active - Recruiting

  • Southwest Women's Oncology

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Active - Recruiting

  • Stephenson Cancer Center (Oklahoma)

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Active - Recruiting

  • Providence Cancer Institute - Franz Clinic

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • Sarah Cannon Research (SCRI)-Tennessee

    Nashville 11838957, Texas 4736286 37203
    United States

    Active - Recruiting

  • University of Washington

    Seattle 5809844, Washington 5815135 98915
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.