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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brontictuzumab and trifluridine/tipiracil

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

Group Type EXPERIMENTAL

brontictuzumab

Intervention Type DRUG

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

trifluridine/tipiracil

Intervention Type DRUG

Interventions

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brontictuzumab

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

Intervention Type DRUG

trifluridine/tipiracil

Intervention Type DRUG

Other Intervention Names

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OMP-52M51

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No