drugset / Trial / NCT02262910

Study of ES414 in Metastatic Castration-Resistant Prostate Cancer

NCT02262910 ↗

Phase 1 Completed 35 enrolled Aptevo Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of ES414. The primary objective of Stage 2 of the study is to evaluate the clinical activity of ES414 in patients that have or have not received prior chemotherapy. Secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of ES414.

Timeline

Start
2015-01
Primary completion
2018-12
Completion
2019-02-18

Drugs

EvaluationDrugModalityDoseRoute
Subject APVO-414 Unknown 0.2 ug/kg Intravenous
Subject APVO-414 Unknown 2 ug/kg Intravenous
Subject APVO-414 Unknown 25 ug Intravenous
Subject APVO-414 Unknown 300 ug Intravenous

Indications