RecruitingPhase 1NCT05581004

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

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors


Sponsor

Genentech, Inc.

Enrollment

450 participants

Start Date

Oct 20, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called RO7502175, both on its own and in combination with immunotherapy drugs (checkpoint inhibitors), in people with advanced solid tumors that cannot be cured. Researchers want to understand the drug's safety, how the body processes it, and whether it helps shrink tumors. **You may be eligible if...** - You have advanced cancer that has been confirmed by biopsy and cannot be cured - Your cancer can be measured on scans - You are in good physical condition (able to carry out light activity) - You are expected to live at least 12 more weeks - A tumor tissue sample is available **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant during the study - You received any cancer treatment within the past 3 weeks - You have certain other medical conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnzelkitug

Enzelkitug will be administered as per the schedule specified in the respective arms.

DRUGAtezolizumab

Atezolizumab will be administered as per the schedule specified in the respective arms.

DRUGPembrolizumab

Pembrolizumab will be administered as per the schedule specified in the respective arms.


Locations(41)

Stanford University

San Francisco, California, United States

University Of Colorado

Aurora, Colorado, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University Medical Center, Division of Oncology

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The West Clinic - Memphis (Union Ave)

Germantown, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Monash Health Monash Medical Centre

Clayton, Victoria, Australia

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

UZ Antwerpen

Edegem, Belgium

CHU de Liège

Herstal, Belgium

GasthuisZusters Antwerpen

Wilrijk, Belgium

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

Chaïdári, Attica, Greece

Papageorgiou General Hospital of Thessaloniki

Pavlos Melas, Thessaloniki, Greece

Sotiria Thoracic Diseases Hospital of Athens

Athens, Greece

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center - PPDS

Seoul, South Korea

Samsung Medical Center - PPDS

Seoul, South Korea

Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

Seoul, South Korea

ICO Hospitalet- Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, Spain

START MADRID_Hospital Universiario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Karolinska Universitetssjukhuset Solna

Stokholm, Solna, Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05581004


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