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New cancer drug YL211 enters first human tests

NCT ID NCT06384352

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This early-stage trial tests a new drug called YL211 in 155 people with advanced solid tumors who have no standard treatment options left. The study has three parts: first, finding a safe dose; then, confirming that dose; and finally, testing how well it works. The main goals are to check safety and see if tumors shrink.

What this could mean

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

Active substance
YL211 (an antibody-drug conjugate given intravenously)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not be safe or effective. Side effects are unknown, and it will take years before any potential treatment is confirmed.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 500 people

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

Started

May 2024

Expected to finish

Jun 2031

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. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF. 2. Aged ≥18 years. 3. Be able and willing to comply with protocol visits and procedures. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 5. Adequate organ and bone marrow function. For Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)/ gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit. For Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting. For Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy For Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy For Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC Exclusion Criteria: 1. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed. 2. Previously received an ADC consisting of a TopoI 3. Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause). 4. A history of leptomeningeal carcinomatosis or carcinomatous meningitis 5. Brain metastasis, except for the following situations: Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed 6. Clinically significant concomitant pulmonary disease, including but not limited to: A history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

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Conditions

The condition(s) this trial relates to.

colorectal cancer gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma hepatocellular carcinoma intrahepatic bile duct cancer neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 4 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

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

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office

    RECRUITING

    Sarasota, Florida, 34232-6422, United States

  • Gosford Hospital

    RECRUITING

    Gosford, New South Wales, 2250, Australia

  • Monash Health

    RECRUITING

    Melbourne, Australia

  • NEXT Oncology - Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Oncology - Houston

    RECRUITING

    Houston, Texas, 77055, United States

  • NEXT San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • One Clinical Research - Nedlands

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Toronto, Canada

  • Sarah Cannon Research Institute (SCRI) at HealthONE

    RECRUITING

    Denver, Colorado, 80218-1238, United States

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Canada

  • The University of Texas - MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Cincinnati Vontz Center for Molecular Studies

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Wenzhou Medical University - The First Affiliated Hospital

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven

    RECRUITING

    North Haven, Connecticut, 06473-2142, United States

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