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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.
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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health (Monash Medical Centre)
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Kinghorn Cancer Centre
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DarlinghurstAustraliaUnknown status
Linear Clinical Research Ltd
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NedlandsAustraliaUnknown status
UZ Antwerpen
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EdegemBelgiumUnknown status
CHU de Liège
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HerstalBelgiumUnknown status
GasthuisZusters Antwerpen
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WilrijkBelgiumUnknown status
Sir Mortimer B Davis - Jewish General Hospital
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MontrealCanadaUnknown status
Ottawa Hospital Regional Cancer Centre
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OttawaCanadaUnknown status
British Columbia Cancer Agency
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VancouverCanadaUnknown status
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
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BarcelonaSpainUnknown status
Ico L'Hospitalet - Hospital Duran I Reynals
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria
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MálagaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Sotiria Thoracic Diseases Hospital of Athens
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AthensGreeceUnknown status
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA;2nd Department of Cardiology
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ChaïdáriGreeceUnknown status
Asan Medical Center - PPDS
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SeoulSouth KoreaUnknown status
Samsung Medical Center - PPDS
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SeoulSouth KoreaUnknown status
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
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SeoulSouth KoreaUnknown status
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
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AmsterdamNetherlandsUnknown status
Universitair Medisch Centrum Groningen
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GroningenNetherlandsUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Winship Cancer Institute
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AtlantaUnited StatesUnknown status
University of Colorado
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AuroraUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
The West Clinic - Memphis (Union Ave)
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GermantownUnited StatesUnknown status
SCRI Oncology Partners
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NashvilleUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START
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San AntonioUnited StatesUnknown status
Stanford University
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San FranciscoUnited StatesUnknown status
Florida Cancer Specialists - Sarasota
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SarasotaUnited StatesUnknown status
Washington University Medical Center, Division of Oncology
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.