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New drug YL201 enters human trials for Hard-to-Treat cancers

NCT ID NCT05434234

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tests a new drug called YL201 in people with advanced solid tumors that have stopped responding to standard treatments. The trial has two parts: first, finding a safe dose, then testing that dose in more patients with specific cancer types. YL201 is given by IV every three weeks, sometimes combined with another cancer drug called atezolizumab. The goal is to see if it is safe and can shrink tumors.

What this could mean

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

Active substance
YL201 (a drug given by IV infusion every 3 weeks, alone or with atezolizumab)
What this could lead to
If successful, this could lead to 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, first-in-human study, so safety and effectiveness are not yet known. The drug may cause side effects or not shrink tumors as hoped.

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 312 people

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

Started

May 2022

Expected to finish

Oct 2027

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: * Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF * Aged ≥18 years * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Adequate organ and bone marrow function * Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of YL201, whichever is later. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of YL201. * Life expectancy of ≥3 months * Able and willing to comply with protocol visits and procedures * Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC and NSCLC are preferred) for which standard treatment had proven to be ineffective or intolerable, or no standard treatment is available. For ES-SCLC patients in Arm C: no prior anti-cancer treatment Exclusion Criteria: * Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study * Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral fluorouracil \[eg, tegafur and capecitabine\] or small molecular-targeted therapy within 2 weeks or 5 half-life periods \[whichever is shorter\]before the first dose; use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of herbal medicine with antitumor indications or nonspecific immunomodulators \[eg, thymosin, interferon, and interleukin\] within 2 weeks before the first dose). * Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks) * Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study * Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before the first dose of study drug * Received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study * Known human immunodeficiency virus (HIV) infection * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the study site * Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be enrolled after discussion with the sponsor * A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs * Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

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

    43 sites in 5 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • 001

    RECRUITING

    La Jolla, California, 92093-0698, United States

  • 002

    RECRUITING

    Fair Oaks, California, 95628, United States

  • 003

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • 004

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • 005

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • 006

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • 007

    RECRUITING

    Detroit, Michigan, 48292, United States

  • 008

    RECRUITING

    St Louis, Missouri, 63110, United States

  • 009

    RECRUITING

    Santa Fe, New Mexico, 87505-699, United States

  • 010

    RECRUITING

    New York, New York, 10029, United States

  • 011

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • 012

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • 013

    RECRUITING

    San Antonio, Texas, 78229, United States

  • 014

    RECRUITING

    Houston, Texas, 77030, United States

  • 015

    RECRUITING

    Irving, Texas, 75039, United States

  • 016

    RECRUITING

    Tyler, Texas, 75701, United States

  • 017

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • 018

    RECRUITING

    Spokane, Washington, 99208, United States

  • 019

    RECRUITING

    Tacoma, Washington, 98405, United States

  • 020

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • 021

    RECRUITING

    Kelowna, British Columbia, V1Y 1E2, Canada

  • 022

    RECRUITING

    Brampton, Ontario, L6R 3J7, Canada

  • 023

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • 024

    COMPLETED

    Guangzhou, Guangdong, 510000, China

  • 025

    COMPLETED

    Zhengzhou, Henan, 450003, China

  • 026

    RECRUITING

    Bordeaux, 33000, France

  • 027

    RECRUITING

    Dijon, 21000, France

  • 028

    RECRUITING

    Marseille, 13005, France

  • 029

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • 030

    NOT_YET_RECRUITING

    Paris, 75248, France

  • 031

    RECRUITING

    Poitiers, 86021, France

  • 032

    NOT_YET_RECRUITING

    Saint-Herblain, 44800, France

  • 033

    RECRUITING

    Suresnes, 92150, France

  • 034

    RECRUITING

    Barcelona, Barcelona, 08023, Spain

  • 035

    RECRUITING

    Barcelona, Barcelona, 08025, Spain

  • 036

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • 037

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • 038

    RECRUITING

    Moncloa-Aravaca, Madrid, 28040, Spain

  • 039

    NOT_YET_RECRUITING

    Leganés, Madrid, 28911, Spain

  • 040

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • 041

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • 042

    RECRUITING

    Usera, Madrid, 28041, Spain

  • 043

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • 044

    RECRUITING

    Otwock, 05-400, Poland

  • 045

    NOT_YET_RECRUITING

    Poznan, 60-569, Poland

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