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Spots Global Cancer Trial Database for First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)

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Trial Identification

Brief Title: First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)

Official Title: A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours

Study ID: NCT03852511

Interventions

NG-350A

Study Description

Brief Summary: This study will evaluate the safety, tolerability and preliminary efficacy and also pharmacokinetics, immunogenicity and other pharmacodynamic effects to elucidate the mechanism of action of NG-350A, either alone or in combination with a check point inhibitor, in patients with advanced or metastatic epithelial tumours.

Detailed Description: Phase Ia of this study is a dose escalation phase, investigating NG-350A administration by intravenous (IV) infusion, either alone or in combination with a check point inhibitor. Phase Ib of this study comprises of a Combination Dose Efficacy Expansion with NG-350A in combination with a check point inhibitor.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California, Los Angeles (UCLA), Santa Monica, California, United States

University of Colorado, Aurora, Colorado, United States

Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York, United States

Cleveland Clinic, Cleveland, Ohio, United States

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Aung Naing, MD

Affiliation: The University of Texas MD Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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