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Clinical Trials in South Korea / NCT05581004
Active, not recruiting Phase 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

NCT05581004 · tracked via the Priya Life Science South Korea tracker
Sponsor
Genentech, Inc
Phase
Phase 1
Started
2022-10-20
Last updated
2026-08-06

Condition(s) studied

Locally Advanced or Metastatic Solid TumorsNSCLCHNSCCMelanomaTNBCEsophageal CancerGastric CancerCervical CancerColorectal CancerUrothelial CarcinomaClear Cell RCCHCC

Investigational drug(s) / intervention(s)

EnzelkitugAtezolizumab →Pembrolizumab →

Enzelkitug: Enzelkitug will be administered as per the schedule specified in the respective arms.

Atezolizumab: Atezolizumab will be administered as per the schedule specified in the respective arms.

Pembrolizumab: Pembrolizumab will be administered as per the schedule specified in the respective arms.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs) — From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
  • Phase Ib: Number of Participants With DLTs — From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
  • Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — Up to approximately 52 months
  • Phase Ib: Number of Participants With TEAEs — Up to approximately 52 months

Trial sites (36)

FacilityCityRegionStatus
Stanford University San Francisco California
University Of Colorado Aurora Colorado
Florida Cancer Specialists - Sarasota Sarasota Florida
Winship Cancer Institute Atlanta Georgia
Dana Farber Cancer Institute Boston Massachusetts
Washington University Medical Center, Division of Oncology St Louis Missouri
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
The West Clinic - Memphis (Union Ave) Germantown Tennessee
SCRI Oncology Partners Nashville Tennessee
IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START San Antonio Texas
Kinghorn Cancer Centre Darlinghurst New South Wales
Monash Health Monash Medical Centre Clayton Victoria
Linear Clinical Research Ltd Nedlands Western Australia
UZ Antwerpen Edegem Belgium
CHU de Liège Herstal Belgium
GasthuisZusters Antwerpen Wilrijk Belgium
British Columbia Cancer Agency Vancouver British Columbia
Ottawa Hospital Regional Cancer Centre Ottawa Ontario
Princess Margaret Cancer Centre Toronto Ontario
Sir Mortimer B Davis Jewish General Hospital Montreal Quebec
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA Chaïdári Attica
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 Barcelona
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
Karolinska Universitetssjukhuset Solna Stokholm, Solna Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Taiwan

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05581004 on ClinicalTrials.gov ↗ ← All trials in South Korea