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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
To evalue the DLTs — Approximately within 36 months
To evalue the TEAEs — Approximately within 36 months Treatment Emergent Adverse Event
To evalue the TRAEs — Approximately within 36 months Treatment Related Adverse Event
To evalue the serious adverse events (SAEs) — Approximately within 36 months
Determination of the MTD of YL205 in the pivotal clinical study — Approximately within 36 months
Determination of the RED of YL205 in the pivotal clinical study — Approximately within 36 months
Determination of the RP2D of YL205 in the pivotal clinical study — Approximately within 36 months
Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1 — Approximately within 36 months
Trial sites (43)
Facility
City
Region
Status
Sarah Cannon Research Institute (SCRI)- Denver
Denver
Colorado
Recruiting
Yale Cancer Center
New Haven
Connecticut
Recruiting
Florida Cancer Specialists - Lake Mary
Lake Mary
Florida
Recruiting
Norton Cancer Institute
Louisville
Kentucky
Recruiting
Washington University School of Medicine - Center for advanced Medicine
St Louis
Missouri
Recruiting
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas
Nevada
Recruiting
Southwest Women's Oncology
Albuquerque
New Mexico
Recruiting
Stephenson Cancer Center (Oklahoma)
Oklahoma City
Oklahoma
Recruiting
Providence Cancer Institute - Franz Clinic
Portland
Oregon
Recruiting
Sarah Cannon Research (SCRI)-Tennessee
Nashville
Texas
Recruiting
University of Washington
Seattle
Washington
Recruiting
Fujian Provincial Cancer Hospital
Fuzhou
Fujian
Recruiting
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou
Guangdong
Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Recruiting
Hainan General Hospital
Haikou
Hainan
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Anyang Cancer Hospital
Anyang
Henan
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Jingzhou First People's Hospital
Jingzhou
Hubei
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Tongji Medical College of Hust TongJi Hospital
Wuhan
Hubei
Recruiting
Union hospital Tongji Medical Colllege Huazhong University of School and Technology
Wuhan
Hubei
Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Hubei
Recruiting
Hunan Provincial Cancer Hospital
Changsha
Hunan
Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
Jilin Provincial Cancer Hospital
Changchun
Jilin
Recruiting
Liaoning Cancer Hospital
Shenyang
Liaoning
Recruiting
The People's Hospital of Liaoning Province
Shenyang
Liaoning
Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan
Shandong
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
Linyi Cancer Hospital
Linyi
Shandong
Recruiting
Shanxi Cancer Hospital
Taiyuan
Shanxi
Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an
Shanxi
Recruiting
West China Second University Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Recruiting
The First Affiliated Hospital. Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
Peking Union Medical College Hospital
Beijing
China
Recruiting
Chinese People's Liberation Army Army Characterstic Medical Center
Chongqing
China
Recruiting
+ 3 more sites — see the full list on the official registry below.
More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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