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Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-05-01
Completion Date
2031-06-30
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
YL211
Patients will be treated with YL211 intravenous (IV) infusion only.
YL211+Pembrolizumab
Patients will be treated with YL211 and Pembro by infusion.
YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)
participants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)
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
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