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NCT05434234PHASE1, PHASE2Recruiting

A Study of YL201 in Patients With Advanced Solid Tumors

MediLink Therapeutics (Suzhou) Co., Ltd.

Start Date

5/25/2022

Completion Date

10/6/2027

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

YL201

DRUG

YL201

DRUG

YL201 and atezolizumab

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Conditions

Advanced Solid Tumor

Locations

002

Fair Oaks, California 95628

United States

001

La Jolla, California 92093-0698

United States

003

Lone Tree, Colorado 80124

United States

004

Washington D.C., District of Columbia 20007

United States

005

Boston, Massachusetts 02114

United States

006

Ann Arbor, Michigan 48109

United States

007

Detroit, Michigan 48292

United States

008

St Louis, Missouri 63110

United States

009

Santa Fe, New Mexico 87505-699

United States

010

New York, New York 10029

United States

011

Chapel Hill, North Carolina 27514

United States

012

Nashville, Tennessee 37203

United States

014

Houston, Texas 77030

United States

015

Irving, Texas 75039

United States

013

San Antonio, Texas 78229

United States

016

Tyler, Texas 75701

United States

017

Fairfax, Virginia 22031

United States

018

Spokane, Washington 99208

United States

019

Tacoma, Washington 98405

United States

020

Edmonton, Alberta T6G 1Z2

Canada

021

Kelowna, British Columbia V1Y 1E2

Canada

022

Brampton, Ontario L6R 3J7

Canada

023

Toronto, Ontario M5G 2C4

Canada

024

Guangzhou, Guangdong 510000

China

025

Zhengzhou, Henan 450003

China

026

Bordeaux, 33000

France

027

Dijon, 21000

France

028

Marseille, 13005

France

029

Nantes, 44093

France

030

Paris, 75248

France

031

Poitiers, 86021

France

032

Saint-Herblain, 44800

France

033

Suresnes, 92150

France

044

Otwock, 05-400

Poland

045

Poznan, 60-569

Poland

034

Barcelona, Barcelona 08023

Spain

035

Barcelona, Barcelona 08025

Spain

039

Leganés, Madrid 28911

Spain

037

Madrid, Madrid 28034

Spain

036

Madrid, Madrid 28050

Spain

038

Moncloa-Aravaca, Madrid 28040

Spain

041

Pozuelo de Alarcón, Madrid 28223

Spain

042

Usera, Madrid 28041

Spain

040

Pamplona, Navarre 31008

Spain

043

Valencia, Valencia 46010

Spain