Recent Updates
Recently added Catalysts

brontictuzumab

Phase 1

Metastatic Colorectal Cancer | Monoclonal antibody | Oncology |Mereo BioPharma Group plc|Trials Updated: Sep 9, 2020

brontictuzumab development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Oct 2012

brontictuzumab target and mechanism

Molecular targetNOTCH1
Target classInhibitor
ModalityMonoclonal antibody

Also known as OMP-52M51

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials3
Total Enrollment79

FDA Designations

No designations recorded

brontictuzumab clinical trials

brontictuzumab · 3 trials · 3 indications

Phase 1 3
NCT03031691A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED7 Analytics
NCT01778439A Dose Escalation Study of OMP-52M51 in Subjects With Solid TumorsRelapsed or Refractory Solid Tumors
COMPLETED48 Analytics
NCT01703572A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid MalignanciesRelapsed or Refractory Lymphoid Malignancies
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors
Relapsed or Refractory Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
Relapsed or Refractory Lymphoid MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Safety profile of OMP-52M51 in subjects with relapsed or refractory solid tumors
Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Brontictuzumab and trifluridine/tipiracilEXPERIMENTALBrontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
OMP-52M51EXPERIMENTAL -

Interventions

NameTypeDescription
brontictuzumabDRUGstarting dose of 1.5mg/kg administered intravenously (IV)
trifluridine/tipiracilDRUG -
OMP-52M51DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 Crit...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Colorectal Cancer 361 trials (matched to "Metastatic Colorectal Cancer")

Unlock Competitive Intelligence

Frequently asked questions about brontictuzumab

What is brontictuzumab used for?

Brontictuzumab is an investigational monoclonal antibody being studied for metastatic colorectal cancer. It has been evaluated in combination with chemotherapy in previously treated patients whose tumors are biomarker selected. It is not an approved therapy and remains in clinical development.

What does brontictuzumab target?

Brontictuzumab targets NOTCH1, a cell surface receptor in the NOTCH signaling pathway. It acts as an inhibitor of NOTCH1 signaling. Targeting this receptor is intended to interfere with tumor cell signaling in cancers that depend on NOTCH1 activity.

Who is developing brontictuzumab?

Brontictuzumab is being developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company holds the asset as part of its oncology pipeline.

What phase is brontictuzumab in?

Brontictuzumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The completed Phase 1 study enrolled seven patients with metastatic colorectal cancer.

What clinical trials is brontictuzumab in?

Brontictuzumab has been studied in one clinical trial, NCT03031691, titled A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer. That Phase 1 trial is completed, was conducted in the United States, and enrolled seven patients.

Was the brontictuzumab trial randomized or blinded?

The Phase 1 trial of brontictuzumab, NCT03031691, was an uncontrolled, non-randomized, open-label study. It enrolled seven adults aged 18 years and older with previously treated metastatic colorectal cancer, and it did not use a placebo or comparator arm.