A Study of YL201 in Patients With Advanced Solid Tumors

NCT05434234 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YL201-INT-101-01
• Study Type: interventional
• Target: 312
• Locations: 6 countries
• Sites: 45

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Antibody-drug conjugate

Outcome Measures

Primary Outcomes (7)

• Evaluate the occurrence of DLTs during the first cycle in Part 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

  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

  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

  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

  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

  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

  At the end of cycle 1 (each cycle is 21 days)

Secondary Outcomes (18)

• Evaluate the AEs in Part 1 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

  By the global end of trial date, approximately within 36 months

• Characterize the PK parameter AUC

  Approximately within 36 months

• Characterize the PK parameter Cmax

  Approximately within 36 months

• Characterize the PK parameter Ctrough

  Approximately within 36 months

• Characterize the PK parameter CL

  Approximately within 36 months

Study Arms (3)

Dose escalation

EXPERIMENTAL

All participants enrolled in the dose escalation part

Drug: YL201

Dose expansion

EXPERIMENTAL

All participants enrolled in the dose expansion part

Drug: YL201

Dose Selection

EXPERIMENTAL

Drug: YL201 and atezolizumab

Interventions

YL201 DRUG

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.

Dose escalation

YL201 and atezolizumab DRUG

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

Dose Selection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (45)

002

Fair Oaks, California, 95628, United States

RECRUITING

001

La Jolla, California, 92093-0698, United States

RECRUITING

003

Lone Tree, Colorado, 80124, United States

RECRUITING

004

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

RECRUITING

005

Boston, Massachusetts, 02114, United States

RECRUITING

006

Ann Arbor, Michigan, 48109, United States

RECRUITING

007

Detroit, Michigan, 48292, United States

RECRUITING

008

St Louis, Missouri, 63110, United States

RECRUITING

009

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

RECRUITING

010

New York, New York, 10029, United States

RECRUITING

011

Chapel Hill, North Carolina, 27514, United States

RECRUITING

012

Nashville, Tennessee, 37203, United States

RECRUITING

014

Houston, Texas, 77030, United States

RECRUITING

015

Irving, Texas, 75039, United States

RECRUITING

013

San Antonio, Texas, 78229, United States

RECRUITING

016

Tyler, Texas, 75701, United States

RECRUITING

017

Fairfax, Virginia, 22031, United States

RECRUITING

018

Spokane, Washington, 99208, United States

RECRUITING

019

Tacoma, Washington, 98405, United States

RECRUITING

020

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

021

Kelowna, British Columbia, V1Y 1E2, Canada

RECRUITING

022

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

023

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

024

Guangzhou, Guangdong, 510000, China

COMPLETED

025

Zhengzhou, Henan, 450003, China

COMPLETED

026

Bordeaux, 33000, France

RECRUITING

027

Dijon, 21000, France

RECRUITING

028

Marseille, 13005, France

RECRUITING

029

Nantes, 44093, France

NOT YET RECRUITING

030

Paris, 75248, France

NOT YET RECRUITING

031

Poitiers, 86021, France

RECRUITING

032

Saint-Herblain, 44800, France

NOT YET RECRUITING

033

Suresnes, 92150, France

RECRUITING

044

Otwock, 05-400, Poland

RECRUITING

045

Poznan, 60-569, Poland

NOT YET RECRUITING

034

Barcelona, Barcelona, 08023, Spain

RECRUITING

035

Barcelona, Barcelona, 08025, Spain

RECRUITING

039

Leganés, Madrid, 28911, Spain

NOT YET RECRUITING

037

Madrid, Madrid, 28034, Spain

RECRUITING

036

Madrid, Madrid, 28050, Spain

RECRUITING

038

Moncloa-Aravaca, Madrid, 28040, Spain

RECRUITING

041

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

042

Usera, Madrid, 28041, Spain

RECRUITING

040

Pamplona, Navarre, 31008, Spain

RECRUITING

043

Valencia, Valencia, 46010, Spain

RECRUITING

Related Publications (1)

• Ma Y, Yang Y, Huang Y, Fang W, Xue J, Meng X, Fan Y, Fu S, Wu L, Zheng Y, Liu J, Liu Z, Zhuang W, Rosen S, Qu S, Li B, Li M, Zhao Y, Yang S, Ji Y, Sommerhalder D, Luo S, Yang K, Li J, Lv D, Zhang P, Zhao Y, Hong S, Zhang Y, Zhao S, Chin S, Zhang X, Lian W, Cai J, Xue T, Zhang L, Zhao H. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. Nat Med. 2025 Jun;31(6):1949-1957. doi: 10.1038/s41591-025-03600-2. Epub 2025 Mar 13.

  PMID: 40082695 DERIVED

MeSH Terms

Interventions

atezolizumab

Central Study Contacts

Sasha Stann

CONTACT

617-240-8494; info@medilinkthera.com

Alan Xu, Ph.D.

CONTACT

617-871-9455; info@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: May 25, 2022
• Primary Completion (Estimated): April 6, 2027
• Study Completion (Estimated): October 6, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); US (19); CA (4); FR (8); PL (2); ES (10)