A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06459973

Run by

MediLink Therapeutics (Suzhou) Co., Ltd.

People needed

252

Starts

2024-06-04

Expected to finish

2030-07-31

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.
• 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.
• 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 may not qualify if…

• 1) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.
• 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.
• Subjects with an insufficient washout period from the previous anti-tumor therapy to the first dose.
• Subjects who received radiotherapy, including palliative stereotactic radiotherapy on the abdomen, within 4 weeks prior to the first dose.
• Subjects who received major surgery within 4 weeks prior to the first dose or those who plan to receive major surgery during the study.
• Subjects who received allogeneic bone marrow transplantation or solid organ transplantation.
• Subjects who received systemic steroids or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational drug.
• 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.
• Subjects with a medical history of leptomeningeal carcinoma or cancerous meningitis.
• Subjects with brain metastasis or spinal cord compression. 12) Subjects with uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
• Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects with significantly symptomatic or unstable effusion in the third space requiring repeated drainage.
• 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.
• Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to the first dose.
• 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.
• 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.
• Female subjects who are pregnant as confirmed by a pregnancy test within 3 days prior to the first dose, or lactating women.
• Subjects who have any diseases, medical conditions, organ system dysfunction, or social conditions.
• 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.

Where it is running

• Sarah Cannon Research Institute (SCRI)- Denver — Denver, Colorado, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists - Lake Mary — Lake Mary, Florida, United States (enrolling)
• Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
• Washington University School of Medicine - Center for advanced Medicine — St Louis, Missouri, United States (enrolling)
• Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley — Las Vegas, Nevada, United States (enrolling)
• Southwest Women's Oncology — Albuquerque, New Mexico, United States (enrolling)
• Stephenson Cancer Center (Oklahoma) — Oklahoma City, Oklahoma, United States (enrolling)
• Providence Cancer Institute - Franz Clinic — Portland, Oregon, United States (enrolling)
• Sarah Cannon Research (SCRI)-Tennessee — Nashville, Texas, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Hainan General Hospital — Haikou, Hainan, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Anyang Cancer Hospital — Anyang, Henan, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Jingzhou First People's Hospital — Jingzhou, Hubei, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Tongji Medical College of Hust TongJi Hospital — Wuhan, Hubei, China (enrolling)
• Union hospital Tongji Medical Colllege Huazhong University of School and Technology — Wuhan, Hubei, China (enrolling)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• Hunan Provincial Cancer Hospital — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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