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NCT05581004PHASE1Recruiting

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

Genentech, Inc.

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

Inclusion Criteria: * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * Tumor specimen availability Exclusion Criteria: * Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis * Positive test for human immunodeficiency virus (HIV) infection * Acute or chronic active Epstein-Barr virus (EBV) infection at screening * Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Active or history of autoimmune disease * Prior allogeneic stem cell or organ transplantation

Interventions

DRUG

Enzelkitug

DRUG

Atezolizumab

DRUG

Pembrolizumab

Interested in This Trial?

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Conditions

Locally Advanced or Metastatic Solid TumorsNSCLCHNSCCMelanomaTNBCEsophageal CancerGastric CancerCervical CancerColorectal CancerUrothelial CarcinomaClear Cell RCCHCC

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