Phase I Study of LFA102 in Patients With Advanced Breast Cancer or Castration-resistant Prostate Cancer.


Journal

Anticancer research
ISSN: 1791-7530
Titre abrégé: Anticancer Res
Pays: Greece
ID NLM: 8102988

Informations de publication

Date de publication:
Sep 2020
Historique:
received: 21 07 2020
revised: 27 07 2020
accepted: 28 07 2020
entrez: 4 9 2020
pubmed: 4 9 2020
medline: 20 9 2020
Statut: ppublish

Résumé

The prolactin receptor (PRLR) is implicated in the tumorigenesis of breast and prostate cancers where it drives cell proliferation, survival, and migration. LFA102 is a humanized monoclonal antibody against PRLR with promising preclinical antitumor activity. To determine the maximum tolerated dose or a recommended dose, and to delineate the pharmacokinetic profile of LFA102 in Japanese patients, we conducted a phase I study. LFA102 was intravenously infused every 4 weeks to patients with advanced breast or castration-resistant prostate cancer, and the dose increased from 3 to 40 mg/kg. Fourteen patients were treated, and toxicities were reported in 9 (64%) patients. They were all grade 1 or 2, and the most frequently observed toxicity was nausea (3 patients, 21%). No dose-limiting toxicities were observed. LFA102 did not show antitumor activity as a single agent. Treatment with LFA102 was well tolerated.

Sections du résumé

BACKGROUND/AIM OBJECTIVE
The prolactin receptor (PRLR) is implicated in the tumorigenesis of breast and prostate cancers where it drives cell proliferation, survival, and migration. LFA102 is a humanized monoclonal antibody against PRLR with promising preclinical antitumor activity. To determine the maximum tolerated dose or a recommended dose, and to delineate the pharmacokinetic profile of LFA102 in Japanese patients, we conducted a phase I study.
PATIENTS AND METHODS METHODS
LFA102 was intravenously infused every 4 weeks to patients with advanced breast or castration-resistant prostate cancer, and the dose increased from 3 to 40 mg/kg.
RESULTS RESULTS
Fourteen patients were treated, and toxicities were reported in 9 (64%) patients. They were all grade 1 or 2, and the most frequently observed toxicity was nausea (3 patients, 21%). No dose-limiting toxicities were observed. LFA102 did not show antitumor activity as a single agent.
CONCLUSION CONCLUSIONS
Treatment with LFA102 was well tolerated.

Identifiants

pubmed: 32878811
pii: 40/9/5229
doi: 10.21873/anticanres.14526
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Antineoplastic Agents, Immunological 0
Biomarkers, Tumor 0
LFA102 monoclonal antibody 0

Types de publication

Clinical Trial, Phase I Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

5229-5235

Informations de copyright

Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Auteurs

Hironobu Minami (H)

Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan hminami@med.kobe-u.ac.jp.

Yuichi Ando (Y)

Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.

Kenji Tamura (K)

Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.

Takeshi Tajima (T)

Novartis Pharma K.K., Tokyo, Japan.

Randi Isaacs (R)

Novartis Pharmaceuticals Corporation, East Hanover, NJ, U.S.A.

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Classifications MeSH