Back to Trials
NCT06459973PHASE1, PHASE2Recruiting

A Clinical Study of YL205 in Patients With Advanced Solid Tumors

MediLink Therapeutics (Suzhou) Co., Ltd.

Start Date

6/4/2024

Completion Date

7/31/2030

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

intravenous (IV) infusion

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Advanced Solid Tumors

Locations

Sarah Cannon Research Institute (SCRI)- Denver

Denver, Colorado 80218

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Florida Cancer Specialists - Lake Mary

Lake Mary, Florida 32746

United States

Norton Cancer Institute

Louisville, Kentucky 40241

United States

Washington University School of Medicine - Center for advanced Medicine

St Louis, Missouri 63110

United States

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada 89169

United States

Southwest Women's Oncology

Albuquerque, New Mexico 87109

United States

Stephenson Cancer Center (Oklahoma)

Oklahoma City, Oklahoma 73104

United States

Providence Cancer Institute - Franz Clinic

Portland, Oregon 97213

United States

Sarah Cannon Research (SCRI)-Tennessee

Nashville, Texas 37203

United States

University of Washington

Seattle, Washington 98915

United States

Fujian Provincial Cancer Hospital

Fuzhou, Fujian

China

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

Guangzhou, Guangdong

China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi

China

Hainan General Hospital

Haikou, Hainan

China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang

China

Anyang Cancer Hospital

Anyang, Henan

China

Henan Cancer Hospital

Zhengzhou, Henan

China

Jingzhou First People's Hospital

Jingzhou, Hubei

China

Hubei Cancer Hospital

Wuhan, Hubei

China

Tongji Medical College of Hust TongJi Hospital

Wuhan, Hubei

China

Union hospital Tongji Medical Colllege Huazhong University of School and Technology

Wuhan, Hubei

China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei

China

Hunan Provincial Cancer Hospital

Changsha, Hunan

China

Xiangya Hospital of Central South University

Changsha, Hunan

China

Jilin Provincial Cancer Hospital

Changchun, Jilin

China

Liaoning Cancer Hospital

Shenyang, Liaoning

China

The People's Hospital of Liaoning Province

Shenyang, Liaoning

China

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong

China

Qilu Hospital of Shandong University

Jinan, Shandong

China

Shandong Cancer Hospital

Jinan, Shandong

China

Linyi Cancer Hospital

Linyi, Shandong

China

Shanxi Cancer Hospital

Taiyuan, Shanxi

China

The First Affiliated Hospital of XI'AN Jiaotong University

Xi’an, Shanxi

China

West China Second University Hospital, Sichuan University

Chengdu, Sichuan

China

Yunnan Cancer Hospital

Kunming, Yunnan

China

The First Affiliated Hospital. Zhejiang University School of Medicine

Hangzhou, Zhejiang

China

Peking Union Medical College Hospital

Beijing,

China

Chinese People's Liberation Army Army Characterstic Medical Center

Chongqing,

China

Chongqing Cancer Hospital

Chongqing,

China

The Southwest Hospital of AMU

Chongqing,

China

Obstetrics & Gynecology Hospital of Fudan University

Shanghai,

China