A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
NCT ID: NCT06384352
Last Updated: 2026-01-02
Study Results
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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RECRUITING
PHASE1
155 participants
INTERVENTIONAL
2024-05-01
2029-04-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1: Dose-Escalation Part
Dose-Escalation Part
YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Part 2: Backfill Enrollment Part
Backfill Enrollment Part
YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Part 3: Dose-Expansion Part
Dose-Expansion Part
YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Interventions
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YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
MediLink Therapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
NEXT San Antonio
San Antonio, Texas, United States
Gosford Hospital
Gosford, New South Wales, Australia
One Clinical Research - Nedlands
Nedlands, Western Australia, Australia
Monash Health
Melbourne, , Australia
Princess Margaret Hospital
Toronto, Toronto, Canada
The Ottawa Hospital - General Campus
Ottawa, , Canada
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Wenzhou Medical University - The First Affiliated Hospital
Wenzhou, Zhejiang, China
West China Hospital, Sichuan University
Chengdu, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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site coordinator
Role: primary
site coordinator
Role: primary
site coordinator
Role: primary
site coordinator
Role: primary
site coordinator
Role: primary
site coordinator
Role: primary
Other Identifiers
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YL211-INT-101-01
Identifier Type: -
Identifier Source: org_study_id
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