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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031691
• Other study ID #: 52M51-003
• Status: Completed
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: August 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• brontictuzumab
starting dose of 1.5mg/kg administered intravenously (IV)
• trifluridine/tipiracil

Locations

Country	Name	City	State
United States	Charleston	Charleston	South Carolina
United States	Denver	Denver	Colorado
United States	Miami	Miami	Florida
United States	Nashville	Nashville	Tennessee
United States	Sarasota	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
OncoMed Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with adverse events		up to approximately 2 years
Primary	Percentage of patients with dose limiting toxicities		28 days
Primary	Percentage of patients with anti-brontictuzumab antibodies		up to approximately 2 years
Secondary	Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)		approximately 2 years
Secondary	Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1		approximately 2 years
Secondary	Changes in number of circulating tumor cells		approximately 2 years
Secondary	Overall survival		approximately 2 years