Phase 1/2 study of intratumoral G100 (TLR4 agonist) with or without pembrolizumab in follicular lymphoma.


Journal

Leukemia & lymphoma
ISSN: 1029-2403
Titre abrégé: Leuk Lymphoma
Pays: United States
ID NLM: 9007422

Informations de publication

Date de publication:
04 2022
Historique:
pubmed: 7 12 2021
medline: 21 4 2022
entrez: 6 12 2021
Statut: ppublish

Résumé

Intratumoral injection of G100, a toll-like receptor 4 (TLR4) agonist, was shown pre-clinically to stimulate anti-tumor immune responses and tumor regression. This open-label, multicenter, phase 1/2 trial evaluated the safety, tolerability, and preliminary efficacy of intratumoral G100 injections following localized low-dose radiation in patients with follicular lymphoma (ClinicalTrials.gov #NCT02501473). The study was comprised of a G100 dose escalation (5 or 10 µg/dose, or 20 µg/dose for large tumors); a randomized component comparing G100 to G100 plus pembrolizumab; and G100 20 µg/dose expansion. Adverse events grade ≥3 were uncommon in patients treated with G100, and no unexpected toxicities were observed when combined with pembrolizumab. G100 20 µg (

Identifiants

pubmed: 34865586
doi: 10.1080/10428194.2021.2010057
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
TLR4 protein, human 0
Toll-Like Receptor 4 0
pembrolizumab DPT0O3T46P

Banques de données

ClinicalTrials.gov
['NCT02501473']

Types de publication

Clinical Trial, Phase I Clinical Trial, Phase II Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

821-833

Auteurs

Ahmad S Halwani (AS)

Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.

Carlos Panizo (C)

Department of Hematology and Hemotherapy, Clínica Universidad de Navarra; Instituto de Investigación Sanitaria de Navarra, University of Navarra, Pamplona, Spain.

Iris Isufi (I)

Department of Medicine (Hematology), Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA.

Alex F Herrera (AF)

Department of Hematology & Hematopoietic Cell Transportation, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.

Craig Y Okada (CY)

Division of Hematology and Hematologic Malignancies, Oregon Health and Science University, Portland, OR, USA.

Elizabeth H Cull (EH)

Medical Oncology and Hematology Oncology, Prisma Health, Greenville, SC, USA.

Bela Kis (B)

Diagnostic Imaging and Interventional Radiology, Moffitt Cancer Center, Tampa, FL, USA.

Jorge M Chaves (JM)

Medical Oncology, Northwest Medical Specialties, Tacoma, WA, USA.

Nancy L Bartlett (NL)

Division of Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.

Weiyun Ai (W)

Department of Medicine (Hematology/Oncology), Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.

Luis de la Cruz-Merino (L)

Department of Clinical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.
Department of Medicine, University of Seville, Seville, Spain.

Locke J Bryan (LJ)

Department of Medicine, Augusta University, Augusta, GA, USA.

Roch Houot (R)

Department of Hematology, CHU Rennes, University of Rennes, Rennes, France.

Kim Linton (K)

Medical Oncology, The Christie NHS Foundation Trust & The University of Manchester, Manchester, United Kingdom.

Javier Briones (J)

Department of Hematology, Hospital De La Santa Creu I Sant Pau, Barcelona, Spain.

Ian Chau (I)

Lymphoma Unit, Royal Marsden Hospital, London & Surrey, United Kingdom.

Gottfried R von Keudell (GR)

Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, NY, USA.

Hailing Lu (H)

Immune Design, South San Francisco, CA, USA.

Adam Yakovich (A)

Immune Design, South San Francisco, CA, USA.

Michael Chen (M)

Immune Design, South San Francisco, CA, USA.

Ter Meulen Jh (T)

Immune Design, South San Francisco, CA, USA.
Obsidian Therapeutics, Inc., Cambridge, MA, USA.

Sergey Yurasov (S)

Immune Design, South San Francisco, CA, USA.

Frank J Hsu (FJ)

Immune Design, South San Francisco, CA, USA.

Christopher R Flowers (CR)

Winship Cancer Institute, Emory University, Atlanta, GA, USA.
CPRIT Scholar in Cancer Research, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

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Classifications MeSH