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A Study of YL201 in Patients With Advanced Solid Tumors

NCT ID: NCT05434234

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2027-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumor

Keywords

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Antibody-drug conjugate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

All participants enrolled in the dose escalation part

Group Type EXPERIMENTAL

YL201

Intervention Type DRUG

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

Dose expansion

All participants enrolled in the dose expansion part

Group Type EXPERIMENTAL

YL201

Intervention Type DRUG

Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.

Dose Selection

Group Type EXPERIMENTAL

YL201 and atezolizumab

Intervention Type 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

Interventions

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YL201

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

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MediLink Therapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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002

Fair Oaks, California, United States

Site Status RECRUITING

001

La Jolla, California, United States

Site Status RECRUITING

003

Lone Tree, Colorado, United States

Site Status RECRUITING

004

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

Site Status RECRUITING

005

Boston, Massachusetts, United States

Site Status RECRUITING

006

Ann Arbor, Michigan, United States

Site Status RECRUITING

007

Detroit, Michigan, United States

Site Status RECRUITING

008

St Louis, Missouri, United States

Site Status RECRUITING

009

Santa Fe, New Mexico, United States

Site Status RECRUITING

010

New York, New York, United States

Site Status RECRUITING

011

Chapel Hill, North Carolina, United States

Site Status RECRUITING

012

Nashville, Tennessee, United States

Site Status RECRUITING

014

Houston, Texas, United States

Site Status RECRUITING

015

Irving, Texas, United States

Site Status RECRUITING

013

San Antonio, Texas, United States

Site Status RECRUITING

016

Tyler, Texas, United States

Site Status RECRUITING

017

Fairfax, Virginia, United States

Site Status RECRUITING

018

Spokane, Washington, United States

Site Status RECRUITING

019

Tacoma, Washington, United States

Site Status RECRUITING

020

Edmonton, Alberta, Canada

Site Status RECRUITING

021

Kelowna, British Columbia, Canada

Site Status RECRUITING

022

Brampton, Ontario, Canada

Site Status RECRUITING

023

Toronto, Ontario, Canada

Site Status RECRUITING

024

Guangzhou, Guangdong, China

Site Status COMPLETED

025

Zhengzhou, Henan, China

Site Status COMPLETED

026

Bordeaux, , France

Site Status RECRUITING

027

Dijon, , France

Site Status RECRUITING

028

Marseille, , France

Site Status RECRUITING

029

Nantes, , France

Site Status NOT_YET_RECRUITING

030

Paris, , France

Site Status NOT_YET_RECRUITING

031

Poitiers, , France

Site Status RECRUITING

032

Saint-Herblain, , France

Site Status NOT_YET_RECRUITING

033

Suresnes, , France

Site Status RECRUITING

044

Otwock, , Poland

Site Status RECRUITING

045

Poznan, , Poland

Site Status NOT_YET_RECRUITING

034

Barcelona, Barcelona, Spain

Site Status RECRUITING

035

Barcelona, Barcelona, Spain

Site Status RECRUITING

039

Leganés, Madrid, Spain

Site Status NOT_YET_RECRUITING

037

Madrid, Madrid, Spain

Site Status RECRUITING

036

Madrid, Madrid, Spain

Site Status RECRUITING

038

Moncloa-Aravaca, Madrid, Spain

Site Status RECRUITING

041

Pozuelo de Alarcón, Madrid, Spain

Site Status RECRUITING

042

Usera, Madrid, Spain

Site Status RECRUITING

040

Pamplona, Navarre, Spain

Site Status RECRUITING

043

Valencia, Valencia, Spain

Site Status RECRUITING

Countries

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United States Canada China France Poland Spain

Central Contacts

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Sasha Stann

Role: CONTACT

Phone: 617-240-8494

Email: [email protected]

Alan Xu, Ph.D.

Role: CONTACT

Phone: 617-871-9455

Email: [email protected]

Facility Contacts

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Study Coordinator

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Site Coordinator

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References

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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.

Reference Type DERIVED
PMID: 40082695 (View on PubMed)

Other Identifiers

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YL201-INT-101-01

Identifier Type: -

Identifier Source: org_study_id