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A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

NCT06384352•MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined. Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211. Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
•2. Aged ≥18 years.
•3. Be able and willing to comply with protocol visits and procedures.
•4. History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
•5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
•6. Adequate organ and bone marrow function.
•7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria

•1. Inadequate washout period for prior anticancer treatment before the first dose of study drug.
•2. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
•3. Clinically significant concomitant pulmonary disease.
•4. Uncontrolled infection that requires systemic therapy within 2 weeks before the first dose.
•5. Unresolved toxicities from previous anticancer therapy.
•6. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.

Locations (21)

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Sarah Cannon Research Institute (SCRI) at HealthONE

Denver, Colorado, United States

Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven

North Haven, Connecticut, United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office

Sarasota, Florida, United States

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, United States

University of Cincinnati Vontz Center for Molecular Studies

Cincinnati, Ohio, United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology - Houston

Houston, Texas, United States

NEXT Oncology - Dallas

Irving, Texas, United States

Key Dates

Start Date

May 1, 2024

Primary Completion Date

April 7, 2027

Completion Date

April 7, 2029

Last Updated

January 2, 2026

Enrollment

155

ESTIMATED participants

Conditions

Advanced Solid Tumors

Interventions

YL211

DRUG

Contacts

MediLink Study Team

CONTACT

+86 0512-62858368 clinicaltrials@medilinkthera.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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