First-in-Human Study of Utomilumab, a 4-1BB/CD137 Agonist, in Combination with Rituximab in Patients with Follicular and Other CD20


Journal

Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500

Informations de publication

Date de publication:
01 06 2020
Historique:
received: 17 10 2019
revised: 17 02 2020
accepted: 03 03 2020
pubmed: 8 3 2020
medline: 4 9 2021
entrez: 8 3 2020
Statut: ppublish

Résumé

In this phase I study (NCT01307267), we evaluated safety, pharmacokinetics, clinical activity, and pharmacodynamics of treatment with utomilumab plus rituximab in patients with relapsed/refractory follicular lymphoma (FL) and other CD20 Primary objectives were to assess treatment safety and tolerability for estimating the MTD, using a modified time-to-event continual reassessment method, and selecting the recommended phase II dose (RP2D). Sixty-seven patients received utomilumab (0.03-10.0 mg/kg every 4 weeks) and rituximab (375 mg/m Utomilumab in combination with rituximab demonstrated clinical activity and a favorable safety profile in patients with CD20

Identifiants

pubmed: 32144134
pii: 1078-0432.CCR-19-2973
doi: 10.1158/1078-0432.CCR-19-2973
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Antigens, CD20 0
Immunoglobulin G 0
TNFRSF9 protein, human 0
Tumor Necrosis Factor Receptor Superfamily, Member 9 0
Rituximab 4F4X42SYQ6
utomilumab 6YY8O697VF

Banques de données

ClinicalTrials.gov
['NCT01307267']

Types de publication

Clinical Trial, Phase I Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2524-2534

Informations de copyright

©2020 American Association for Cancer Research.

Auteurs

Ajay K Gopal (AK)

University of Washington, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington. AGopal@u.washington.edu.

Ronald Levy (R)

Stanford Cancer Center, Stanford, California.

Roch Houot (R)

1 CHU Rennes, Service Hématologie Clinique Rennes, France.
University of Rennes, EFS, Microenvironment, Cell Differentiation, Immunology and Cancer Rennes, France.
INSERM 0203, Unité d'Investigation Clinique, Rennes, France.

Sandip P Patel (SP)

University of California at San Diego Moores Cancer Center, San Diego, California.

Leslie Popplewell (L)

City of Hope National Medical Center, Duarte, California.

Caron Jacobson (C)

Dana-Farber Cancer Institute, Boston, Massachusetts.

Xinmeng J Mu (XJ)

Pfizer Oncology, San Diego, California.

Shibing Deng (S)

Pfizer Oncology, San Diego, California.

Keith A Ching (KA)

Pfizer Oncology, San Diego, California.

Ying Chen (Y)

Pfizer Oncology, San Diego, California.

Craig B Davis (CB)

Pfizer Oncology, San Diego, California.

Bo Huang (B)

Pfizer Oncology, Groton, Connecticut.

Kolette D Fly (KD)

Pfizer Oncology, Groton, Connecticut.

Aron Thall (A)

Pfizer Oncology, San Diego, California.

Adrian Woolfson (A)

Pfizer Oncology, New York, New York.

Nancy L Bartlett (NL)

Washington University School of Medicine, Siteman Cancer Center, St Louis, Missouri.

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Classifications MeSH