Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Start Date
5/1/2024
Completion Date
6/30/2031
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)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
YL211
YL211+Pembrolizumab
YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)
Conditions
Locations
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado 80045
United States
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado 80218-1238
United States
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
North Haven, Connecticut 06473-2142
United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida 32827
United States
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
Sarasota, Florida 34232-6422
United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada 89169
United States
University of Cincinnati Vontz Center for Molecular Studies
Cincinnati, Ohio 45219
United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology - Houston
Houston, Texas 77055
United States
NEXT Oncology - Dallas
Irving, Texas 75039
United States
NEXT San Antonio
San Antonio, Texas 78229
United States
Gosford Hospital
Gosford, New South Wales 2250
Australia
One Clinical Research - Nedlands
Nedlands, Western Australia 6009
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 100029
China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
China
Wenzhou Medical University - The First Affiliated Hospital
Wenzhou, Zhejiang 325000
China
West China Hospital, Sichuan University
Chengdu,
China
Sun Yat-sen University Cancer Center
Guangzhou,
China