A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Start Date
10/20/2022
Completion Date
7/31/2028
Summary
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Enzelkitug
Atezolizumab
Pembrolizumab
Conditions
Locations
Stanford University
San Francisco, California 94305
United States
University Of Colorado
Aurora, Colorado 80045
United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232
United States
Winship Cancer Institute
Atlanta, Georgia 30322
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Washington University Medical Center, Division of Oncology
St Louis, Missouri 63110
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
The West Clinic - Memphis (Union Ave)
Germantown, Tennessee 38138
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START
San Antonio, Texas 78229
United States
Kinghorn Cancer Centre
Darlinghurst, New South Wales 2010
Australia
Monash Health Monash Medical Centre
Clayton, Victoria 3168
Australia
Linear Clinical Research Ltd
Nedlands, Western Australia 6009
Australia
UZ Antwerpen
Edegem, 2650
Belgium
CHU de Liège
Herstal, 4040
Belgium
GasthuisZusters Antwerpen
Wilrijk, 2610
Belgium
British Columbia Cancer Agency
Vancouver, British Columbia V5Z 4E6
Canada
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 1Z5
Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Attica 124 62
Greece
Papageorgiou General Hospital of Thessaloniki
N. Efkapria-Pavlos Melas, Thessaloniki 564 03
Greece
Sotiria Thoracic Diseases Hospital of Athens
Athens, 115 27
Greece
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center - PPDS
Seoul, 05505
South Korea
Samsung Medical Center - PPDS
Seoul, 06351
South Korea
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Seoul, 120-752
South Korea
ICO l?Hospitalet ? Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 08035
Spain
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario 12 De Octubre
Madrid, 28041
Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Sweden
Karolinska Universitetssjukhuset Solna
Stokholm, Solna, 17176
Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
Chung Shan Medical University Hospital
Taichung, 40201
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan