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New drug YL205 aims to shrink advanced tumors in early trial

NCT ID NCT06459973

Disease control Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug, YL205, in 252 people with advanced solid tumors that have spread or cannot be removed by surgery. The drug is given by IV every three weeks. The main goals are to check safety, find the right dose, and see if it helps shrink tumors. This is an early-stage trial, so the main focus is on safety and dosing, not yet on proving it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
YL205 (an experimental drug given by IV infusion every 3 weeks)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants, so the drug may not prove effective or may have unexpected side effects. It is also only being tested in China, so results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endometrial cancer non-small cell lung carcinoma ovarian cancer renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, China

  • Central Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, Shandong, China

  • Chinese People's Liberation Army Army Characterstic Medical Center

    RECRUITING

    Chongqing, China

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, China

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Florida Cancer Specialists - Lake Mary

    RECRUITING

    Lake Mary, Florida, 32746, United States

  • Fujian Provincial Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Hainan General Hospital

    RECRUITING

    Haikou, Hainan, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Hunan Provincial Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jilin Provincial Cancer Hospital

    RECRUITING

    Changchun, Jilin, China

  • Jingzhou First People's Hospital

    RECRUITING

    Jingzhou, Hubei, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, Liaoning, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40241, United States

  • Obstetrics & Gynecology Hospital of Fudan University

    RECRUITING

    Shanghai, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Providence Cancer Institute - Franz Clinic

    RECRUITING

    Portland, Oregon, 97213, United States

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, China

  • Sarah Cannon Research (SCRI)-Tennessee

    RECRUITING

    Nashville, Texas, 37203, United States

  • Sarah Cannon Research Institute (SCRI)- Denver

    RECRUITING

    Denver, Colorado, 80218, United States

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Southwest Women's Oncology

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Stephenson Cancer Center (Oklahoma)

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

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

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of XI'AN Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital. Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The People's Hospital of Liaoning Province

    RECRUITING

    Shenyang, Liaoning, China

  • The Southwest Hospital of AMU

    RECRUITING

    Chongqing, China

  • Tongji Medical College of Hust TongJi Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Union hospital Tongji Medical Colllege Huazhong University of School and Technology

    RECRUITING

    Wuhan, Hubei, China

  • University of Washington

    RECRUITING

    Seattle, Washington, 98915, United States

  • Washington University School of Medicine - Center for advanced Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West China Second University Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

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Other studies related to the condition(s) this trial covers.