A Study of YL201 in Patients With Advanced Solid Tumors

Last updated: November 7, 2025
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

YL201 and atezolizumab

YL201

Clinical Study ID

NCT05434234
YL201-INT-101-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed of the trial before the start of the trial and voluntarily sign their nameand 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 formof contraception and not donate, or retrieve for their own use, ova from the time ofscreening and throughout the study period, and for at least 5 months after the lastdose 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 notfreeze 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 inSolid Tumors (RECIST) version 1.1.

  • Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC andNSCLC are preferred) for which standard treatment had proven to be ineffective orintolerable, or no standard treatment is available. For ES-SCLC patients in Arm C:no prior anti-cancer treatment

Exclusion

Exclusion Criteria:

  • Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of aninterventional study

  • Prior systemic anticancer treatment including chemotherapy, molecular -targetedtherapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeksbefore the first dose of study drug (use of oral fluorouracil [eg, tegafur andcapecitabine] or small molecular-targeted therapy within 2 weeks or 5 half-lifeperiods [whichever is shorter]before the first dose; use of mitomycin ornitrosoureas within 6 weeks before the first dose; use of herbal medicine withantitumor indications or nonspecific immunomodulators [eg, thymosin, interferon, andinterleukin] 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 stereotacticradiation therapy without abdominal, within 2 weeks)

  • Undergone major surgery (not including diagnostic surgery) within 4 weeks before thefirst dose of study drug or expect major surgery during the study

  • Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the firstdose of study drug, or autologous HSCT within 3 months before the first dose ofstudy drug

  • Received systemic steroids (>10 mg/day of prednisone or its equivalent) or otherimmunosuppressive 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 orintend 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 isdefined 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 aspositive hepatitis C antibody and HCV RNA level above ULN at the study site

  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (otherthan alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, orthe level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication maybe enrolled after discussion with the sponsor

  • A history of severe hypersensitivity reactions to the drug substances, inactiveingredients in the drug product, or other mAbs

  • Women who are breastfeeding or pregnant as confirmed by pregnancy tests performedwithin 7 days before the first dose

Study Design

Total Participants: 312
Treatment Group(s): 2
Primary Treatment: YL201 and atezolizumab
Phase: 1/2
Study Start date:
May 25, 2022
Estimated Completion Date:
October 06, 2027

Connect with a study center

  • Cross Cancer Institute - Alberta Health Services; Siu Chung Chu Professional Corporation

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • 020

    Edmonton 5946768, Alberta 5883102 T6G 1Z2
    Canada

    Active - Recruiting

  • 021

    Kelowna 5990579, British Columbia 5909050 V1Y 1E2
    Canada

    Active - Recruiting

  • 022

    Brampton 5907364, Ontario 6093943 L6R 3J7
    Canada

    Active - Recruiting

  • 023

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • 024

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Completed

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • 025

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Completed

  • CHU de Bordeaux - Hopital Saint Andre

    Bordeaux, 33000
    France

    Site Not Available

  • 026

    Bordeaux 3031582, 33000
    France

    Active - Recruiting

  • Centre Georges-Francois Leclerc

    Dijon, 21000
    France

    Site Not Available

  • 027

    Dijon 3021372, 21000
    France

    Active - Recruiting

  • APHM - Hopital Nord

    Marseille, 13915
    France

    Site Not Available

  • 028

    Marseille 2995469, 13005
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • 029

    Nantes 2990969, 44093
    France

    Site Not Available

  • Institut Curie - Site Paris

    Paris, 75248
    France

    Site Not Available

  • 030

    Paris 2988507, 75248
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86000
    France

    Site Not Available

  • 031

    Poitiers 2986495, 86021
    France

    Active - Recruiting

  • Institut de cancerologie de l'Ouest - Site Saint Herblain

    Saint-Herblain, 44800
    France

    Site Not Available

  • 032

    Saint-Herblain 2979590, 44800
    France

    Site Not Available

  • Hopital Foch

    Suresnes, 92150
    France

    Site Not Available

  • 033

    Suresnes 2973675, 92150
    France

    Active - Recruiting

  • Europejskie Centrum Zdrowia Otwock Sp. z.o.o.

    Otwock, 05-400
    Poland

    Site Not Available

  • 044

    Otwock 762788, 05-400
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • 045

    Poznan 3088171, 60-569
    Poland

    Site Not Available

  • 034

    Barcelona 3128760, Barcelona 08023
    Spain

    Active - Recruiting

  • 035

    Barcelona 3128760, Barcelona 08025
    Spain

    Active - Recruiting

  • Hospital Universitario Severo Ochoa

    Leganes, Madrid 28911
    Spain

    Site Not Available

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Moncloa-Aravaca, Madrid 28040
    Spain

    Site Not Available

  • NEXT Oncology Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Usera, Madrid 28041
    Spain

    Site Not Available

  • 039

    Leganés 3118594, Madrid 3117732 28911
    Spain

    Site Not Available

  • 036

    Madrid 3117735, Madrid 3117732 28050
    Spain

    Active - Recruiting

  • 037

    Madrid 3117735, Madrid 3117732 28034
    Spain

    Active - Recruiting

  • 038

    Moncloa-Aravaca 6544099, Madrid 3117732 28040
    Spain

    Active - Recruiting

  • 041

    Pozuelo de Alarcón 3112989, Madrid 3117732 28223
    Spain

    Active - Recruiting

  • 042

    Usera 6544490, Madrid 3117732 28041
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • 040

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • 043

    Valencia 2509954, Valencia 2593113 46010
    Spain

    Active - Recruiting

  • Hospital de la Santa creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • START Madrid - Centro Integral Oncologico Clara Campal (CIOCC) - Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • University California San Diego Moores Cancer Center

    La Jolla, California 92093-0698
    United States

    Site Not Available

  • 002

    Fair Oaks 5347287, California 5332921 95628
    United States

    Active - Recruiting

  • 001

    La Jolla 5363943, California 5332921 92093-0698
    United States

    Active - Recruiting

  • 003

    Lone Tree 5429208, Colorado 5417618 80124
    United States

    Active - Recruiting

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • 004

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Active - Recruiting

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida 34952
    United States

    Site Not Available

  • Hematology Oncology Associates of the Treasure Coast

    Port St. Lucie, Florida 34952
    United States

    Site Not Available

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Mass General Cancer Center: Hematology

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • 005

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Michigan - Rogel Cancer Center - Urology Oncology Clinic

    Detroit, Michigan 48201-2013
    United States

    Site Not Available

  • 006

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • 007

    Detroit 4990729, Michigan 5001836 48292
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • 008

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • CHRISTUS St. Vincent Health System - CHRISTUS St. Vincent Regional Cancer Center (Andrea Teague)

    Santa Fe, New Mexico 87505-699
    United States

    Site Not Available

  • 009

    Santa Fe 5490263, New Mexico 5481136 87505-699
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • 010

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • 011

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Active - Recruiting

  • 012

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • NEXT Oncology-Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • UT Health East Texas HOPE Cancer Center

    Tyler, Texas 75701
    United States

    Site Not Available

  • 014

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • 015

    Irving 4700168, Texas 4736286 75039
    United States

    Active - Recruiting

  • 013

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • 016

    Tyler 4738214, Texas 4736286 75701
    United States

    Active - Recruiting

  • Inova Schar Cancer Institute - Inova Fairfax Hospital Location

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • 017

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

  • Medical Oncology Associates and Summit Cancer Centers

    Spokane, Washington 99208
    United States

    Site Not Available

  • Northwest Medical Specialties

    Tacoma, Washington 98405
    United States

    Site Not Available

  • 018

    Spokane 5811696, Washington 5815135 99208
    United States

    Active - Recruiting

  • 019

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

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