NCT03031691

A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer

A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.

Detailed description

This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for up to 24 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. Approximately 34 patients will be enrolled in this study at approximately 5 study centers in the United States.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	brontictuzumab	starting dose of 1.5mg/kg administered intravenously (IV)
DRUG	trifluridine/tipiracil

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-05-01
• Completion: 2017-09-01
• First posted: 2017-01-25
• Last updated: 2020-08-11

Locations

5 sites across 1 country: United States