NCT05581004Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 12 Oct 2022
- Start date
- 20 Oct 2022
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Genentech, Inc.
- Diseases
- Head and neck cancer, Kidney cancer, Bladder cancer, Melanoma, Cervical cancer, Colorectal cancer, Gastric and esophageal cancer
- NCT number
- NCT05581004
- EU CT number
- 2023-504709-35-00
- EudraCT number
- 2021-006708-34
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 165
- From 20 Oct 2022 to the primary completion date, 31 Jul 2028
- 32 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion
- Prior allogeneic stem cell or organ transplantation
Other illness
- 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
- Active or history of autoimmune disease
Other
- 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
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health (Monash Medical Centre) Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Kinghorn Cancer Centre Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Linear Clinical Research Ltd Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| CHU de Liège Coordinator of this site? Confirm its status | Herstal | Belgium | Unknown status |
| GasthuisZusters Antwerpen Coordinator of this site? Confirm its status | Wilrijk | Belgium | Unknown status |
| Sir Mortimer B Davis - Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Regional Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| British Columbia Cancer Agency Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Ico L'Hospitalet - Hospital Duran I Reynals Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Sotiria Thoracic Diseases Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA;2nd Department of Cardiology Coordinator of this site? Confirm its status | Chaïdári | Greece | Unknown status |
| Asan Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The West Clinic - Memphis (Union Ave) Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Florida Cancer Specialists - Sarasota Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Washington University Medical Center, Division of Oncology Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.