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New cancer drug YL201 enters human testing for advanced tumors

NCT ID NCT06057922

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug, YL201, in about 990 people with advanced solid tumors like lung, prostate, and liver cancers. The goal is to check safety and see if tumors shrink. It is an early-stage trial, so the drug is not yet proven to work.

What this could mean

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

Active substance
YL201 (an experimental drug given by IV infusion every 3 weeks)
What this could lead to
If it works, this could point toward a new treatment option for several advanced cancers that have stopped responding to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not shrink tumors or may cause significant side effects. Success is far from guaranteed.

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 990 people

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

Started

Sep 2023

Expected to finish

Oct 2028

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 to 75 years

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: * Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF. * Age ≥18 years old and ≤75 years old * Histologically or cytologically confirmed at diagnosis of NSCLC/SCLC/NPC/ESCC /mCRPC/HNSCC/Sarcoma/PDAC/HCC/BTC * At least one extracranial measurable lesion according to RECIST 1.1. * Archived or fresh tumor tissue samples can be provided. * Eastern Cooperative Oncology Group - performance scale (ECOG PS) score of 0 or 1. * Female subjects with fertility must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug. Male subjects must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug. * Life expectancy ≥3 months. * Capable or willing to observe the visits and procedures stipulated in study protocol. Exclusion Criteria: * Prior treatment with products targeting B7H3 (including antibodies, antibody-drug conjugate \[ADC\], chimeric antigen receptor T cells \[CAR-T\], and other drugs). * Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1 inhibitors. * Participation in another clinical trial meanwhile, except observatory (non-interventional) clinical trial or at follow-up period of interventional study. * Washout period of previous anticancer treatment was insufficient before first administration of investigational drug. * Major surgery (excluding diagnostic surgery) within 4 weeks before first administration of investigational drug or likely to require major surgery during the study. * History of allogenic bone marrow transplantation or solid organ transplantation. * Treatment with systemic steroid (Prednisone \>10 mg/d or equivalent drugs) or other immunosuppressive drugs within 2 weeks before first administration of investigational drug. * Live vaccination within 4 weeks before first administration of investigational drug or likely to require live vaccine inoculation during the study. * Evidence of leptomeningeal metastasis or carcinomatous meningitis. * Evidence of brain metastasis or spinal cord compression. * Evidence of cardiovascular disease with uncontrolled state or clinical significance. * Clinically significant concomitant lung disease. * Diagnosed as Gilbert syndrome. * Complicated with uncontrolled third-space effusion . * History of gastrointestinal perforation and/or fistula within 6 months before first administration. * History of serious infection (Grade ≥3 of NCI CTCAE) before first administration. * Known as infection with human immunodeficiency virus (HIV). * Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). * History of any other primary malignant tumor within 5 years before first administration of investigational drug. * The toxicity of previous anticancer treatment is not resolved. * History of serious hypersensitive reactions to drug substance, inactive compositions of preparations or other monoclonal antibodies. * Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3 days before first administration. * Any disease, medical state, organ/system dysfunction or social state considered by investigators as possibly interfering the subject's capability for ICF signing, producing adverse influence on the subject's capability for cooperation and study participation or influencing the interpretation of study results. Including but not limited to mental disease or substance/alcohol abuse.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer castration-resistant prostate carcinoma esophageal squamous cell carcinoma head and neck squamous cell carcinoma hepatocellular carcinoma metastatic prostate carcinoma nasopharyngeal carcinoma non-small cell lung carcinoma pancreatic ductal adenocarcinoma sarcoma small cell lung carcinoma

As listed by the trial registrant

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

Advanced solid tumor

Contacts and locations

Locations

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, China

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, China

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, China

  • Dongguan People's Hospital

    Dongguan, Guangdong, China

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, China

  • Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)

    Nanchang, Jiangxi, China

  • Jiangyin People's Hospital

    Wuxi, Jiangsu, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, China

  • Linyi Cancer Hospital

    Linyi, Shandong, China

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, China

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, China

  • Nantong Tumor Hospital

    Nantong, Jiangsu, China

  • Peking University People's Hospital

    Beijing, Beijing Municipality, China

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, China

  • Shandong Provincial Hospital

    Jinan, Shandong, China

  • Shanxi Cancer Hospital

    Datong, Shanxi, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, China

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

    Guangzhou, Guangdong, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, China

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of USTC

    Hefei, Anhui, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Hospital of Jilin University

    Changchun, Jilin, China

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, China

  • The Frist People's Hospital of Foshan

    Foshan, Guangdong, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, China

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, China

  • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

    Xian, Shanxi, China

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    Huaxi, Sichuan, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, China

  • Yuebei People's Hospital

    Shaoguan, Guangdong, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

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