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Study identifier: NCT05581004 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Locally Advanced or Metastatic Solid Tumors · NSCLC · HNSCC  ·  Sponsor: Genentech, Inc.

PhasePhase 1
Planned participants450
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: GO43860 https://forpatients.roche.com/  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (41)

Stanford UniversitySan Francisco, California, United StatesRecruiting
University Of ColoradoAurora, Colorado, United StatesRecruiting
Florida Cancer Specialists - SarasotaSarasota, Florida, United StatesRecruiting
Winship Cancer InstituteAtlanta, Georgia, United StatesCompleted
Dana Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
Henry Ford HospitalDetroit, Michigan, United StatesRecruiting
Washington University Medical Center, Division of OncologySt Louis, Missouri, United StatesCompleted
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesRecruiting
The West Clinic - Memphis (Union Ave)Germantown, Tennessee, United StatesRecruiting
SCRI Oncology PartnersNashville, Tennessee, United StatesRecruiting
IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC STARTSan Antonio, Texas, United StatesRecruiting
Kinghorn Cancer CentreDarlinghurst, New South Wales, AustraliaRecruiting

+ 29 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05581004