A Clinical Study of YL205 in Patients With Advanced Solid Tumors

NCT06459973 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YL205-CN-101-01
• Study Type: interventional
• Target: 252
• Locations: 2 countries
• Sites: 43

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (8)

• To evalue the DLTs

  Approximately within 36 months

• To evalue the TEAEs

  Treatment Emergent Adverse Event

  Approximately within 36 months

• To evalue the TRAEs

  Treatment Related Adverse Event

  Approximately within 36 months

• 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

Secondary Outcomes (14)

• Characterize the PK parameter AUC

  Approximately within 36 months

• Characterize the PK parameter Cmax

  Approximately within 36 months

• Characterize the PK parameter Ctrough

  Approximately within 36 months

• Characterize the PK parameter Vd

  Approximately within 36 months

• Characterize the PK parameter CL

  Approximately within 36 months

Study Arms (3)

Phase Ia: Dose escalation portion

EXPERIMENTAL

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.

Drug: intravenous (IV) infusion

Phase Ib: Dose expansion portion

EXPERIMENTAL

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.

Drug: intravenous (IV) infusion

Phase II: Cohort expansion portion

EXPERIMENTAL

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.

Drug: intravenous (IV) infusion

Interventions

intravenous (IV) infusion DRUG

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; Phase Ia: Dose escalation portion; Phase Ib: Dose expansion portion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• ） 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:

• \) 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.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (43)

Sarah Cannon Research Institute (SCRI)- Denver

Denver, Colorado, 80218, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Cancer Specialists - Lake Mary

Lake Mary, Florida, 32746, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40241, United States

RECRUITING

Washington University School of Medicine - Center for advanced Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, 89169, United States

RECRUITING

Southwest Women's Oncology

Albuquerque, New Mexico, 87109, United States

RECRUITING

Stephenson Cancer Center (Oklahoma)

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Cancer Institute - Franz Clinic

Portland, Oregon, 97213, United States

RECRUITING

Sarah Cannon Research (SCRI)-Tennessee

Nashville, Texas, 37203, United States

RECRUITING

University of Washington

Seattle, Washington, 98915, United States

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

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

Guangzhou, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Anyang Cancer Hospital

Anyang, Henan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Jingzhou First People's Hospital

Jingzhou, Hubei, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

RECRUITING

Tongji Medical College of Hust TongJi Hospital

Wuhan, Hubei, China

RECRUITING

Union hospital Tongji Medical Colllege Huazhong University of School and Technology

Wuhan, Hubei, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Hunan Provincial Cancer Hospital

Changsha, Hunan, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jilin Provincial Cancer Hospital

Changchun, Jilin, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

RECRUITING

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

RECRUITING

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

RECRUITING

The First Affiliated Hospital of XI'AN Jiaotong University

Xi’an, Shanxi, China

RECRUITING

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

The First Affiliated Hospital. Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Chinese People's Liberation Army Army Characterstic Medical Center

Chongqing, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, China

RECRUITING

The Southwest Hospital of AMU

Chongqing, China

RECRUITING

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 14, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2030
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (11); CN (32)