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
Running, not enrolling · Phase 1
Conditions studied: Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC, Melanoma, TNBC, Esophageal Cancer, Gastric Cancer, Cervical Cancer, Colorectal Cancer, Urothelial Carcinoma, Clear Cell RCC, HCC
In brief
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.
Key facts
- Study ID
- NCT05581004
- Run by
- Genentech, Inc.
- People needed
- 165
- Starts
- 2022-10-20
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- 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
- Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Active or history of autoimmune disease
- Prior allogeneic stem cell or organ transplantation
Where it is running
- 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
- 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
- IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC 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
- 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
Full record on ClinicalTrials.gov
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