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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 · Genentech, Inc.
In plain English
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Official title
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
About this study
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 criteria
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
Study design
Enrollment target: 450 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-10-20
Estimated completion: 2028-07-31
Last updated: 2026-04-15
Interventions
Drug: EnzelkitugDrug: AtezolizumabDrug: Pembrolizumab
Primary outcomes
- • 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)
Sponsor
Genentech, Inc. · industry
Contacts & investigators
ContactReference Study ID Number: GO43860 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, Genentech, Inc.
All locations (41)
Stanford UniversityRecruiting
San Francisco, California, United States
University Of ColoradoRecruiting
Aurora, Colorado, United States
Florida Cancer Specialists - SarasotaRecruiting
Sarasota, Florida, United States
Winship Cancer InstituteCompleted
Atlanta, Georgia, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Washington University Medical Center, Division of OncologyCompleted
St Louis, Missouri, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
The West Clinic - Memphis (Union Ave)Recruiting
Germantown, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics (START)Recruiting
San Antonio, Texas, United States
Kinghorn Cancer CentreRecruiting
Darlinghurst, New South Wales, Australia
Monash Health Monash Medical CentreRecruiting
Clayton, Victoria, Australia
Linear Clinical Research LtdRecruiting
Nedlands, Western Australia, Australia
UZ AntwerpenRecruiting
Edegem, Belgium
CHU de LiègeRecruiting
Herstal, Belgium
GasthuisZusters AntwerpenRecruiting
Wilrijk, Belgium
British Columbia Cancer AgencyRecruiting
Vancouver, British Columbia, Canada
Ottawa Hospital Regional Cancer CentreRecruiting
Ottawa, Ontario, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General HospitalRecruiting
Montreal, Quebec, Canada
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARARecruiting
Chaïdári, Attica, Greece
Papageorgiou General Hospital of ThessalonikiRecruiting
Pavlos Melas, Thessaloniki, Greece
Sotiria Thoracic Diseases Hospital of AthensRecruiting
Athens, Greece
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek ZiekenhuisRecruiting
Amsterdam, Netherlands
Universitair Medisch Centrum GroningenRecruiting
Groningen, Netherlands
Seoul National University HospitalRecruiting
Seoul, South Korea
Asan Medical Center - PPDSCompleted
Seoul, South Korea
Samsung Medical Center - PPDSRecruiting
Seoul, South Korea
Severance Hospital Yonsei University Health System - Clinical Trials Center PharmacyRecruiting
Seoul, South Korea
ICO Hospitalet- Hospital Duran i ReynalsRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPONRecruiting
Barcelona, Spain
START MADRID_Hospital Universiario Fundacion Jimenez DiazCompleted
Madrid, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Sahlgrenska UniversitetssjukhusetRecruiting
Gothenburg, Sweden
Karolinska Universitetssjukhuset SolnaRecruiting
Stokholm, Solna, Sweden
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan