---
title: A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
nct_id: NCT03031691
overall_status: COMPLETED
phase: PHASE1
sponsor: OncoMed Pharmaceuticals, Inc.
study_type: INTERVENTIONAL
primary_condition: Metastatic Colorectal Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03031691.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03031691"
ct_last_update_post_date: 2020-08-11
last_seen_at: "2026-05-12T06:04:47.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer

**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

**NCT ID:** [NCT03031691](https://clinicaltrials.gov/study/NCT03031691)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 7
- **Lead Sponsor:** OncoMed Pharmaceuticals, Inc.
- **Conditions:** Metastatic Colorectal Cancer
- **Start Date:** 2017-01
- **Completion Date:** 2017-09
- **CT.gov Last Update:** 2020-08-11

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Brontictuzumab and trifluridine/tipiracil** (EXPERIMENTAL) — Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.

## Interventions

- **brontictuzumab** (DRUG) — starting dose of 1.5mg/kg administered intravenously (IV)
- **trifluridine/tipiracil** (DRUG)

## Primary Outcomes

- **Percentage of patients with adverse events** _(time frame: up to approximately 2 years)_
- **Percentage of patients with dose limiting toxicities** _(time frame: 28 days)_
- **Percentage of patients with anti-brontictuzumab antibodies** _(time frame: up to approximately 2 years)_

## Secondary Outcomes

- **Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)** _(time frame: approximately 2 years)_
- **Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1** _(time frame: approximately 2 years)_
- **Changes in number of circulating tumor cells** _(time frame: approximately 2 years)_
- **Overall survival** _(time frame: approximately 2 years)_

## Locations (5)

- Denver, Denver, Colorado, United States
- Miami, Miami, Florida, United States
- Sarasota, Sarasota, Florida, United States
- Charleston, Charleston, South Carolina, United States
- Nashville, Nashville, Tennessee, United States

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.denver|denver|colorado|united states` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `locations.miami|miami|florida|united states` — added _(2026-05-12)_
- `locations.sarasota|sarasota|florida|united states` — added _(2026-05-12)_
- `locations.charleston|charleston|south carolina|united states` — added _(2026-05-12)_
- `locations.nashville|nashville|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03031691.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03031691*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*