A Study of YL201 in Patients With Advanced Solid Tumors

June 17, 2026 updated by: MediLink Therapeutics (Suzhou) Co., Ltd.

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

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.

Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

312

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • 020
        • Contact:
          • Study Coordinator
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1E2
        • Recruiting
        • 021
        • Contact:
          • Study Coordinator
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • 022
        • Contact:
          • Study Coordinator
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • 023
        • Contact:
          • Study Coordinator
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Completed
        • 024
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Completed
        • 025
  • France
      • Bordeaux, France, 33000
        • Recruiting
        • 026
        • Contact:
          • Study Coordinator
      • Dijon, France, 21000
        • Recruiting
        • 027
        • Contact:
          • Study Coordinator
      • Marseille, France, 13005
        • Recruiting
        • 028
        • Contact:
          • Study Coordinator
      • Nantes, France, 44093
        • Not yet recruiting
        • 029
        • Contact:
          • Study Coordinator
      • Paris, France, 75248
        • Not yet recruiting
        • 030
        • Contact:
          • Study Coordinator
      • Poitiers, France, 86021
        • Recruiting
        • 031
        • Contact:
          • Study Coordinator
      • Saint-Herblain, France, 44800
        • Not yet recruiting
        • 032
        • Contact:
          • Study Coordinator
      • Suresnes, France, 92150
        • Recruiting
        • 033
        • Contact:
          • Study Coordinator
  • Poland
      • Otwock, Poland, 05-400
        • Recruiting
        • 044
        • Contact:
          • Study Coordinator
      • Poznan, Poland, 60-569
        • Not yet recruiting
        • 045
        • Contact:
          • Study Coordinator
  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08023
        • Recruiting
        • 034
        • Contact:
          • Study Coordinator
      • Barcelona, Barcelona, Spain, 08025
        • Recruiting
        • 035
        • Contact:
          • Study Coordinator
    • Madrid
      • Leganés, Madrid, Spain, 28911
        • Not yet recruiting
        • 039
        • Contact:
          • Study Coordinator
      • Madrid, Madrid, Spain, 28050
        • Recruiting
        • 036
        • Contact:
          • Study Coordinator
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • 037
        • Contact:
          • Study Coordinator
      • Moncloa-Aravaca, Madrid, Spain, 28040
        • Recruiting
        • 038
        • Contact:
          • Study Coordinator
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • 041
        • Contact:
          • Study Coordinator
      • Usera, Madrid, Spain, 28041
        • Recruiting
        • 042
        • Contact:
          • Study Coordinator
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • 040
        • Contact:
          • Study Coordinator
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Recruiting
        • 043
        • Contact:
          • Study Coordinator
  • United States
    • California
      • Fair Oaks, California, United States, 95628
        • Recruiting
        • 002
        • Contact:
          • Study Coordinator
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • 001
        • Contact:
          • Study Coordinator
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • 003
        • Contact:
          • Study Coordinator
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • 004
        • Contact:
          • Study Coordinator
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • 005
        • Contact:
          • Study Coordinator
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • 006
        • Contact:
          • Study Coordinator
      • Detroit, Michigan, United States, 48292
        • Recruiting
        • 007
        • Contact:
          • Study Coordinator
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • 008
        • Contact:
          • Study Coordinator
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505-699
        • Recruiting
        • 009
        • Contact:
          • Study Coordinator
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • 010
        • Contact:
          • Study Coordinator
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • 011
        • Contact:
          • Study Coordinator
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • 012
        • Contact:
          • Study Coordinator
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • 014
        • Contact:
          • site coordinator
      • Irving, Texas, United States, 75039
        • Recruiting
        • 015
        • Contact:
          • Study Coordinator
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • 013
        • Contact:
          • site coordinator
      • Tyler, Texas, United States, 75701
        • Recruiting
        • 016
        • Contact:
          • Study Coordinator
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • 017
        • Contact:
          • Study Coordinator
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • 018
        • Contact:
          • Study Coordinator
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • 019
        • Contact:
          • Study Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation
All participants enrolled in the dose escalation part
Drug: YL201
Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.
Drug: YL201
Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.
Experimental: Dose expansion
All participants enrolled in the dose expansion part
Drug: YL201
Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.
Drug: YL201
Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.
Experimental: Dose Selection
Drug: YL201 and atezolizumab
Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the occurrence of DLTs during the first cycle in Part 1
Time Frame: 21 days of Cycle 1
21 days of Cycle 1
Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Time Frame: By the global end of trial date, approximately within 36 months
By the global end of trial date, approximately within 36 months
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2
Time Frame: Approximately within 36 months
PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline
Approximately within 36 months
Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Approximately within 36 months
Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2
Time Frame: Biy the end of trial date, approximately within 36 months
Biy the end of trial date, approximately within 36 months
Incidence, nature, and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in Part 3
Time Frame: Biy the end of trial date, approximately within 36 months
Biy the end of trial date, approximately within 36 months
Nature and frequency of dose-limiting toxicities (DLTs), incidence, nature, and severity of laboratory abnormalities in Part 3
Time Frame: At the end of cycle 1 (each cycle is 21 days)
At the end of cycle 1 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize the PK parameter AUC
Time Frame: Approximately within 36 months
Approximately within 36 months
Characterize the PK parameter Cmax
Time Frame: Approximately within 36 months
Approximately within 36 months
Characterize the PK parameter Ctrough
Time Frame: Approximately within 36 months
Approximately within 36 months
Characterize the PK parameter CL
Time Frame: Approximately within 36 months
Approximately within 36 months
Characterize the PK parameter Vd
Time Frame: Approximately within 36 months
Approximately within 36 months
Characterize the PK parameter t1/2
Time Frame: Approximately within 36 months
Approximately within 36 months
Evaluate the AEs in Part 1 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Time Frame: By the global end of trial date, approximately within 36 months
By the global end of trial date, approximately within 36 months
Assess the incidence of anti-YL201 antibodies
Time Frame: Approximately within 36 months
Approximately within 36 months
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 1
Time Frame: Approximately within 36 months
PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline
Approximately within 36 months
Evaluate the PSA progression-free survival (PSA-PFS) for patients with prostate cancer
Time Frame: Approximately within 36 months
PSA-PFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of PSA progression, based on PCWG3 criteria.
Approximately within 36 months
Evaluate the radiological PFS (rPFS) for patients with prostate cancer
Time Frame: Approximately within 36 months
rPFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression or death due to any cause, whichever occurs first, based on RECIST 1.1 and PCWG3 criteria.
Approximately within 36 months
Evaluate the failure-free survival (FFS) for patients with prostate cancer
Time Frame: Approximately within 36 months
FFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression, unequivocal clinical progression, PSA progression or death due to disease progression, whichever occurs first.
Approximately within 36 months
Evaluate the disease control rate (DCR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Approximately within 36 months
Evaluate the duration of response (DoR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. DoR will be assessed for patients with a response (CR or PR) only.
Approximately within 36 months
Evaluate the time to response (TTR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).
Approximately within 36 months
Evaluate the progression-free survival (PFS) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.
Approximately within 36 months
Evaluate the overall survival (OS) for patients with solid tumors
Time Frame: Approximately within 36 months
OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.
Approximately within 36 months
Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 1, Part 2, and Part 3, assessed using RECIST version 1.1
Time Frame: Approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Approximately within 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Estimated)

April 6, 2027

Study Completion (Estimated)

October 6, 2027

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL201-INT-101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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