drugset / Trial / NCT01363947

Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer

NCT01363947 ↗

Phase 1 Completed 87 enrolled Genentech, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

Timeline

Start
2011-06-14
Primary completion
2016-06-03
Completion
2016-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lifastuzumab vedotin Unknown 0.2 mg/kg Intravenous
Subject Lifastuzumab vedotin Unknown 2.4 mg/kg Intravenous
Subject Lifastuzumab vedotin Unknown 2.8 mg/kg Intravenous