Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
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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.
You will not qualify if you...
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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
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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
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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