NCT02175433

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.

Detailed description

The dose escalation study will have two parts: 1. Dose Escalation of AGS67E without myeloid growth factor (GF) 2. Dose Escalation of AGS67E with myeloid growth factor (GF) Subjects will be enrolled sequentially into dose cohorts starting with AGS67E without GF. All subjects will receive a single 30 minute intravenous (IV) infusion of AGS67E once every three weeks. Subjects will continue treatment until disease progression, intolerability of AGS67E, investigator decision or consent withdrawal. This dose escalation will first determine the maximum tolerated dose (MTD) of AGS67E without GF and then determine the MTD of AGS67E with GF. Once an MTD has been established, the study may enroll subjects into respective expansion cohorts of 12 subjects each at doses recommended by the data review team (DRT) (expansion cohort without GF and/or expansion cohort with GF). During dose escalation, the Data Review Team will review cumulative unaudited data on an interim basis to review subject safety, recommend exploring additional doses and/or schedules, or the expansion of existing cohorts.

Conditions

• Relapsed Lymphoid Malignancy
• Refractory Lymphoid Malignancy

Interventions

Type	Name	Description
DRUG	AGS67E	intravenous (IV) infusion

Timeline

• Start date: 2014-10-14
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2014-06-26
• Last updated: 2024-11-01

Locations

5 sites across 2 countries: United States, Canada