Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas.
Por:
Wermke M, Felip E, Gambardella V, Kuboki Y, Morgensztern D, Hamed Z, Liu M, Studeny M, Owonikoko T
Publicada:
1 ago 2022
Ahead of Print:
11 jul 2022
Resumen:
Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.
Filiaciones:
Wermke M:
Tech Univ Dresden, Fac Med, NCT UCC Early Clin Trial Unit, Dresden, Germany
Felip E:
Vall Hebron Univ Hosp, Dept Med Oncol, Barcelona, Spain
Vall Hebron Inst Oncol, Barcelona, Spain
Gambardella V:
Univ Valencia, INCLIVA Biomed Res Inst, Hosp Cl prime inico Univ, Dept Med Oncol, Valencia, Spain
Kuboki Y:
Natl Canc Ctr Hosp East, Dept Expt Therapeut, Kashiwa, Chiba, Japan
Morgensztern D:
Washington Univ, Sch Med, St Louis, MO 63110 USA
Hamed Z:
Boehringer Ingelheim France SAS, Reims, France
Liu M:
Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA
Studeny M:
Boehringer Ingelheim Int GmbH, Ingelheim, Germany
Owonikoko T:
UPMC Hillman Canc Ctr, Div Hematol Oncol, Pittsburgh, PA 15232 USA
hybrid
FULL TEXT
 |
Published Version |
|
| No Accesible |
|