Pasotuxizumab, a BiTE® immune therapy for castration-resistant prostate cancer: Phase I, dose-escalation study findings.
Immunotherapy
; 13(2): 125-141, 2021 02.
Article
en En
| MEDLINE
| ID: mdl-33172323
ABSTRACT
Aim:
We report results of a first-in-human study of pasotuxizumab, a PSMA bispecific T-cell engager (BiTE®) immune therapy mediating T-cell killing of tumor cells in patients with advanced castration-resistant prostate cancer. Patients &methods:
We assessed once-daily subcutaneous (SC) pasotuxizumab. All SC patients developed antidrug antibodies; therefore, continuous intravenous (cIV) infusion was assessed.Results:
A total of 47 patients received pasotuxizumab (SC n = 31, 0.5-172 µg/d; cIV n = 16, 5-80 µg/d). The SC maximum tolerated dose was 172.0 µg/d. A sponsor change stopped the cIV cohort early; maximum tolerated dose was not determined. PSA responders occurred (>50% PSA decline SC, n = 9; cIV, n = 3), including two long-term responders.Conclusion:
Data support pasotuxizumab safety in advanced castration-resistant prostate cancer and represent evidence of BiTE monotherapy efficacy in solid tumors. Clinical trial registration NCT01723475 (ClinicalTrials.gov).Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Métodos Terapéuticos y Terapias MTCI:
Terapias_biologicas
/
Aromoterapia
Asunto principal:
Anticuerpos Biespecíficos
/
Neoplasias de la Próstata Resistentes a la Castración
/
Antineoplásicos Inmunológicos
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
Immunotherapy
Año:
2021
Tipo del documento:
Article
País de afiliación:
Alemania