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brontictuzumab

Phase 1

Metastatic Colorectal Cancer | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Aug 11, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

brontictuzumab · 1 trial · 1 indication

Phase 1 1
NCT03031691A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED7 Analytics
PHASE1COMPLETED
A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock 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

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
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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.

Interventions

NameTypeDescription
brontictuzumabDRUGstarting dose of 1.5mg/kg administered intravenously (IV)
trifluridine/tipiracilDRUG -
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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
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Metastatic Colorectal Cancer")

Frequently asked questions about brontictuzumab

What is brontictuzumab used for in metastatic colorectal cancer?

Brontictuzumab is an investigational drug being studied for the treatment of metastatic colorectal cancer. It was evaluated in a Phase 1 clinical trial in combination with chemotherapy for subjects with previously treated metastatic colorectal cancer. The drug is still in clinical development and is not approved by the FDA.

Who makes brontictuzumab?

Brontictuzumab is being developed by Mereo BioPharma Group plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol MREO. Mereo BioPharma is responsible for the clinical development of brontictuzumab for metastatic colorectal cancer.

What phase is brontictuzumab in?

Brontictuzumab is in Phase 1 clinical development. A Phase 1 study of brontictuzumab in combination with chemotherapy for metastatic colorectal cancer has been completed. The drug remains investigational and has not received FDA approval.

What clinical trials is brontictuzumab in?

Brontictuzumab has been studied in one clinical trial, identified as NCT03031691. This was a Phase 1 study of brontictuzumab with chemotherapy for subjects with previously treated metastatic colorectal cancer. The trial was conducted in the United States and has been completed.

Is brontictuzumab FDA approved?

Brontictuzumab is not FDA approved. It is an investigational drug that has been evaluated in a Phase 1 clinical trial for metastatic colorectal cancer. The drug is still in clinical development and has not been approved for any use.