Actively 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
Led by Genentech, Inc. · Updated on 2026-05-11
450
Participants Needed
41
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- Availability of tumor specimen
You will not qualify if you...
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 4-5 months after last dose of study drugs
- Anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 3 weeks before starting study treatment
- Active hepatitis B or C infection or tuberculosis
- Positive HIV infection test
- Acute or chronic active Epstein-Barr virus infection at screening
- Live, attenuated vaccine within 4 weeks before first enzelkitug infusion
- Symptomatic, untreated, or progressing central nervous system metastases
- Active or history of autoimmune disease
- Prior allogeneic stem cell or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Stanford University
San Francisco, California, United States, 94305
Actively Recruiting
2
University Of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
4
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Completed
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
7
Washington University Medical Center, Division of Oncology
St Louis, Missouri, United States, 63110
Completed
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
9
The West Clinic - Memphis (Union Ave)
Germantown, Tennessee, United States, 38138
Actively Recruiting
10
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 98229
Actively Recruiting
12
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
13
Monash Health Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
14
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
15
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
16
CHU de Liège
Herstal, Belgium, 4040
Actively Recruiting
17
GasthuisZusters Antwerpen
Wilrijk, Belgium, 2610
Actively Recruiting
18
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
19
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
20
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
21
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
22
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Attica, Greece, 124 62
Actively Recruiting
23
Papageorgiou General Hospital of Thessaloniki
Pavlos Melas, Thessaloniki, Greece, 564 03
Actively Recruiting
24
Sotiria Thoracic Diseases Hospital of Athens
Athens, Greece, 115 27
Actively Recruiting
25
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
26
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
27
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
28
Asan Medical Center - PPDS
Seoul, South Korea, 05505
Completed
29
Samsung Medical Center - PPDS
Seoul, South Korea, 06351
Actively Recruiting
30
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Seoul, South Korea, 120-752
Actively Recruiting
31
ICO Hospitalet- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
32
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, Spain, 08035
Actively Recruiting
33
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Completed
34
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
35
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
36
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
37
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 413 45
Actively Recruiting
38
Karolinska Universitetssjukhuset Solna
Stokholm, Solna, Sweden, 17176
Actively Recruiting
39
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
40
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Actively Recruiting
41
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
R
Reference Study ID Number: GO43860 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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