A randomized, double-blind, single-dose study (LAVENDER) to assess the safety, tolerability, pharmacokinetics, and immunogenicity of a combined infusion of ABP 980 and pertuzumab in healthy subjects.
Adult
Antibodies
/ blood
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Biosimilar Pharmaceuticals
/ administration & dosage
Double-Blind Method
Electrocardiography
Healthy Volunteers
Humans
Male
Trastuzumab
/ administration & dosage
ABP 980
Biosimilars
Co-infusion
Pertuzumab
Pharmacokinetics
Safety
Trastuzumab
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
15
03
2021
accepted:
17
07
2021
pubmed:
7
8
2021
medline:
4
1
2022
entrez:
6
8
2021
Statut:
ppublish
Résumé
ABP 980 (KANJINTI This randomized, double-blind, single-dose, 2-arm, parallel-group study (LAVENDER Study) evaluated an intravenous (IV) infusion of ABP 980 (6 mg/kg) plus pertuzumab (420 mg) combined in a single infusion bag relative to an IV infusion of trastuzumab RP (6 mg/kg) plus pertuzumab (420 mg) combined in a single infusion bag given over 60 min. The subjects were followed for 92 days post dosing. A total of 42 subjects were enrolled in the study and treated with investigational product. Due to an operational issue during dosing, the first 6 subjects enrolled in the study were replaced. A total of 36 randomized subjects, n = 18 for ABP 980 plus pertuzumab and n = 18 for trastuzumab RP plus pertuzumab, were treated. Resulting serum concentrations of ABP 980 and trastuzumab RP were similar. There were no serious adverse events, no deaths, and no cardiac disorders during the study. No subject developed anti-drug antibodies throughout the study. This study demonstrated the safety and tolerability of ABP 980 and pertuzumab admixture in a single infusion bag. The safety profiles and pharmacokinetic parameters of ABP 980 and pertuzumab were consistent with what is known for trastuzumab RP and pertuzumab. EudraCT 2018-002903-33.
Identifiants
pubmed: 34355250
doi: 10.1007/s00280-021-04334-x
pii: 10.1007/s00280-021-04334-x
pmc: PMC8484235
doi:
Substances chimiques
ABP-980
0
Antibodies
0
Antibodies, Monoclonal, Humanized
0
Biosimilar Pharmaceuticals
0
pertuzumab
K16AIQ8CTM
Trastuzumab
P188ANX8CK
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
879-886Informations de copyright
© 2021. The Author(s).
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