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

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: brontictuzumab; Drug: trifluridine/tipiracil

• Registration Number: NCT03031691
• Lead Sponsor: OncoMed Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-25
• Primary Completion: 2017-05
• Study Completion: 2017-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brontictuzumab and trifluridine/tipiracil	trifluridine/tipiracil	Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
Brontictuzumab and trifluridine/tipiracil	brontictuzumab	Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with dose limiting toxicities	28 days
Percentage of patients with anti-brontictuzumab antibodies	up to approximately 2 years
Percentage of patients with adverse events	up to approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1	approximately 2 years
Changes in number of circulating tumor cells	approximately 2 years
Overall survival	approximately 2 years

Trial Locations

Locations (5)

Miami; 🇺🇸 Miami, Florida, United States

Denver; 🇺🇸 Denver, Colorado, United States

Sarasota; 🇺🇸 Sarasota, Florida, United States

Charleston; 🇺🇸 Charleston, South Carolina, United States

Nashville; 🇺🇸 Nashville, Tennessee, United States