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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Przewidywana długość życia co najmniej 12 tygodni.
- •Pacjent czuje się na tyle dobrze, aby wykonywać codzienne czynności (stan sprawności ECOG 0 lub 1).
- •Uwidocznione zmiany nowotworowe widoczne w badaniach obrazowych, które można zmierzyć.
- •Potwierdzony laboratoryjnie, nieuleczalny nowotwór litego typu, który jest zaawansowany, nawrotowy lub rozsiany.
- •Dostępność próbki guza do badań.
✗ Disqualifies
- •Kobiety w ciąży, karmiące piersią lub planujące zajść w ciążę w trakcie badania lub po nim.
- •Przyjmowanie jakichkolwiek terapii przeciwnowotworowych (w tym chemioterapii, hormonoterapii, radioterapii) w ciągu ostatnich 3 tygodni przed rozpoczęciem badania.
- •Aktywne infekcje wątroby (WZW typu B lub C) lub gruźlica.
- •Stwierdzone zakażenie wirusem HIV.
- •Aktywne lub leczone choroby autoimmunologiczne.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (41)
Stanford University
San Francisco, United States
University Of Colorado
Aurora, United States
Florida Cancer Specialists - Sarasota
Sarasota, United States
Winship Cancer Institute
Atlanta, United States
Dana Farber Cancer Institute
Boston, United States
Henry Ford Hospital
Detroit, United States
Washington University Medical Center, Division of Oncology
St Louis, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States
The West Clinic - Memphis (Union Ave)
Germantown, United States
SCRI Oncology Partners
Nashville, United States
IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START
San Antonio, United States
Kinghorn Cancer Centre
Darlinghurst, Australia
Monash Health Monash Medical Centre
Clayton, Australia
Linear Clinical Research Ltd
Nedlands, Australia
UZ Antwerpen
Edegem, Belgium
CHU de Liège
Herstal, Belgium
GasthuisZusters Antwerpen
Wilrijk, Belgium
British Columbia Cancer Agency
Vancouver, Canada
Ottawa Hospital Regional Cancer Centre
Ottawa, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal, Canada
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Greece
Papageorgiou General Hospital of Thessaloniki
N. Efkapria-Pavlos Melas, 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 l?Hospitalet ? Hospital Duran i Reynals
L'Hospitalet de Llobregat, 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
Trial contact
Reference Study ID Number: GO43860 https://forpatients.roche.com/
Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
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