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enadenotucirev

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 9, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

enadenotucirev · 1 trial · 3 indications

Phase 1 1
NCT02636036Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial TumorsColorectal Cancer
COMPLETED51 Analytics
PHASE1COMPLETED
Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, nature and severity of adverse events (safety and tolerability) in study of enadenotucirev administered in combination with a PD-1 inhibitor
12 months

Review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death

Maximum Tolerated and/or Maximum Feasible Dose
12 months

Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev administered IV in combination with nivolumab.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
enadenotucirev and nivolumabEXPERIMENTAL -

Interventions

NameTypeDescription
enadenotucirevBIOLOGICAL -
nivolumabBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Adult males or females aged 18 years or over * Disease status: - Diagnosis of metastatic or advanced CRC, UCC, SCCHN, salivary gland cancer or NSCLC not responding to standard therapy or for whom no standard treatment exists * For patients who have received prior PD-1 / PD-L1 ...

Countries:United States
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Frequently asked questions about enadenotucirev

What is enadenotucirev used for?

Enadenotucirev is an investigational monoclonal antibody being studied for the treatment of colorectal cancer. It is also being evaluated in patients with squamous cell carcinoma of the head and neck and other epithelial tumors. The drug is currently in Phase 1 clinical development.

Who makes enadenotucirev?

Enadenotucirev is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced epithelial tumors.

What phase is enadenotucirev in?

Enadenotucirev is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of enadenotucirev in combination with a PD-1 inhibitor has been completed in patients with metastatic or advanced epithelial tumors.

What clinical trials is enadenotucirev in?

Enadenotucirev has been studied in one clinical trial with the identifier NCT02636036. This Phase 1 study evaluated enadenotucirev in combination with a PD-1 inhibitor in subjects with metastatic or advanced epithelial tumors, including colorectal cancer and squamous cell carcinoma of the head and neck. The trial enrolled 51 participants in the United States.

What does enadenotucirev target?

Enadenotucirev is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being studied in combination with a PD-1 inhibitor, suggesting it may modulate immune responses, though the exact mechanism of action remains under investigation.