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

NCT03031691 | Completed Phase 1

• 1 other identifier: 52M51-003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Percentage of patients with adverse events

  up to approximately 2 years

• Percentage of patients with dose limiting toxicities

  28 days

• Percentage of patients with anti-brontictuzumab antibodies

  up to approximately 2 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Brontictuzumab and trifluridine/tipiracil

EXPERIMENTAL

Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.

Drug: brontictuzumab; Drug: trifluridine/tipiracil

Interventions

brontictuzumab DRUG

starting dose of 1.5mg/kg administered intravenously (IV)

Also known as: OMP-52M51

Brontictuzumab and trifluridine/tipiracil

trifluridine/tipiracil DRUG

Brontictuzumab and trifluridine/tipiracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (5)

Denver

Denver, Colorado, United States

Location

Miami

Miami, Florida, United States

Location

Sarasota

Sarasota, Florida, United States

Location

Charleston

Charleston, South Carolina, United States

Location

Nashville

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (5)