Clinical trial Recruiting at 38 sites Phase1; Phase2 Interventional Ages 18 and up

Testing YL201 in patients with advanced solid tumors

Official title: A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Run by MediLink Therapeutics (Suzhou) Co., Ltd. · NCT05434234 · Data updated 2026-11-12

This study is testing a new treatment called YL201 in people with advanced solid tumors that haven't responded to other treatments to see how well it works and what dose is safe.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment312 (estimated)
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
Industry-sponsored
Drugs / interventionsatezolizumab, chemotherapy, immunotherapy, radiation, prednisone
Locations45 sites (Fair Oaks, California and 44 other locations)
StatusRecruiting
StartedMay 25, 2022
Main results expectedApril 6, 2027
Study endsOctober 6, 2027
Registry record updatedJune 22, 2026
Trial IDNCT05434234 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with advanced solid tumors that are unresponsive to standard treatments.

Probably not a fit

Patients with solid tumors that are responsive to existing therapies or those with a life expectancy of less than three months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, multicenter, nonrandomized, open-label study evaluates YL201, an antibody-drug conjugate, in patients with advanced solid tumors that have not responded to existing therapies. The trial consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose (MTD), while the second part involves a dose expansion to further assess safety and efficacy in specific tumor types. The study is being conducted in both China and the United States.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited or no effective therapies.

How similar studies have gone: Other studies involving antibody-drug conjugates have shown promise in treating advanced solid tumors, indicating potential for success with this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • 002
    Fair Oaks, California, United States
    Recruiting
  • 001
    La Jolla, California, United States
    Recruiting
  • 003
    Lone Tree, Colorado, United States
    Recruiting
  • 004
    Washington D.C., District of Columbia, United States
    Recruiting
  • 005
    Boston, Massachusetts, United States
    Recruiting
  • 006
    Ann Arbor, Michigan, United States
    Recruiting
Show 39 more locations
  • 007
    Detroit, Michigan, United States
    Recruiting
  • 008
    St Louis, Missouri, United States
    Recruiting
  • 009
    Santa Fe, New Mexico, United States
    Recruiting
  • 010
    New York, New York, United States
    Recruiting
  • 011
    Chapel Hill, North Carolina, United States
    Recruiting
  • 012
    Nashville, Tennessee, United States
    Recruiting
  • 014
    Houston, Texas, United States
    Recruiting
  • 015
    Irving, Texas, United States
    Recruiting
  • 013
    San Antonio, Texas, United States
    Recruiting
  • 016
    Tyler, Texas, United States
    Recruiting
  • 017
    Fairfax, Virginia, United States
    Recruiting
  • 018
    Spokane, Washington, United States
    Recruiting
  • 019
    Tacoma, Washington, United States
    Recruiting
  • 020
    Edmonton, Alberta, Canada
    Recruiting
  • 021
    Kelowna, British Columbia, Canada
    Recruiting
  • 022
    Brampton, Ontario, Canada
    Recruiting
  • 023
    Toronto, Ontario, Canada
    Recruiting
  • 026
    Bordeaux, France
    Recruiting
  • 027
    Dijon, France
    Recruiting
  • 028
    Marseille, France
    Recruiting
  • 031
    Poitiers, France
    Recruiting
  • 033
    Suresnes, France
    Recruiting
  • 044
    Otwock, Poland
    Recruiting
  • 034
    Barcelona, Barcelona, Spain
    Recruiting
  • 035
    Barcelona, Barcelona, Spain
    Recruiting
  • 037
    Madrid, Madrid, Spain
    Recruiting
  • 036
    Madrid, Madrid, Spain
    Recruiting
  • 038
    Moncloa-Aravaca, Madrid, Spain
    Recruiting
  • 041
    Pozuelo de Alarcón, Madrid, Spain
    Recruiting
  • 042
    Usera, Madrid, Spain
    Recruiting
  • 040
    Pamplona, Navarre, Spain
    Recruiting
  • 043
    Valencia, Valencia, Spain
    Recruiting
  • 024
    Guangzhou, Guangdong, China
    Completed
  • 025
    Zhengzhou, Henan, China
    Completed
  • 029
    Nantes, France
    Not yet recruiting
  • 030
    Paris, France
    Not yet recruiting
  • 032
    Saint-Herblain, France
    Not yet recruiting
  • 045
    Poznan, Poland
    Not yet recruiting
  • 039
    Leganés, Madrid, Spain
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.