NCT02726334

A Phase I, Dose Escalation Study of BNC101 in Patients With Metastatic Colorectal Cancer.

A Phase I, Dose Escalation Study of BNC101 (Anti-LGR5 Humanized Monoclonal Antibody) in Patients With Metastatic Colorectal Cancer.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Bionomics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (which will be the dose recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of movement of the drug within the body, including absorption and distribution) of the study drug, BNC101 when administered intravenously as a single agent or in combination with chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2 lines of chemotherapy.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BNC101 Solution for Infusion	Administration: Administered via IV infusion once a week over 60 minutes (1 hour).
DRUG	BNC101 in combination with FOLFIRI	BNC101 - Starting dose as determined by Arm A portion (one dose level below recommended Phase 2 dose). BNC101 Administration: Administered via IV Infusion once a week over 60 minutes (1 hour). FOLFIRI components: Irinotecan (IRI) - Starting dose 180 mg/m2 (over 90 minutes on Day 1) Leucovorin (LV) - Starting dose 400 mg/m2 (administered over 120 minutes on Day 1 concurrently with IRI) 5-FU bolus - Starting dose 400 mg/m2 (administered after LV on Day 1, then) 5-FU infusion - Starting dose 2400 mg/m2 (administered over 48 hours starting on Day 1) FOLFIRI Cycles are repeated every 14 days.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2016-04-01
• Last updated: 2019-01-16

Locations

4 sites across 1 country: Australia