A Clinical Study of YL205 in Patients With Advanced Solid Tumors
NCT ID: NCT06459973
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
252 participants
INTERVENTIONAL
2024-06-04
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase Ia: Dose escalation portion
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at several dose levels.
intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Phase Ib: Dose expansion portion
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at no less than two dose levels.
intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Phase II: Cohort expansion portion
YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at RP2D.
intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Interventions
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intravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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MediLink Therapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute (SCRI)- Denver
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists - Lake Mary
Lake Mary, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Washington University School of Medicine - Center for advanced Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
Southwest Women's Oncology
Albuquerque, New Mexico, United States
Stephenson Cancer Center (Oklahoma)
Oklahoma City, Oklahoma, United States
Providence Cancer Institute - Franz Clinic
Portland, Oregon, United States
Sarah Cannon Research (SCRI)-Tennessee
Nashville, Texas, United States
University of Washington
Seattle, Washington, 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
Countries
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Facility Contacts
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Coordinator Clinical operation director
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Coordinator Clinical operation director
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Coordinator Clinical operation director
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Other Identifiers
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YL205-CN-101-01
Identifier Type: -
Identifier Source: org_study_id