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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncoMed Pharmaceuticals, Inc.
• Treatments: Trifluridine

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy

• ECOG performance status 0 or 1

Exclusion Criteria:

• Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors

• Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible

• Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug

• Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:

• Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)

• Active peptic ulcer disease

• Known intraluminal metastatic lesion(s) with risk of bleeding