First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody) (FORTITUDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03852511|
Recruitment Status : Active, not recruiting
First Posted : February 25, 2019
Last Update Posted : April 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Epithelial Tumor||Biological: NG-350A||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
Patients in Part A will receive a single cycle of NG-350A study treatment, with three single doses on Days 1, 3 and 5 by IV infusion.
Patients in Part B will receive a single cycle of NG-350A study treatment, with three single doses on Days 1, 3 and 5 by IV infusion, followed by up to 8 cycles of a check point inhibitor.
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 19, 2019|
|Actual Primary Completion Date :||February 4, 2022|
|Estimated Study Completion Date :||May 2022|
Patients will receive three single doses of NG-350A by IV infusion, followed by multiple cycles of check point inhibitor treatment.
NG-350A is oncolytic adenoviral vector which expresses a full length agonist anti-CD40 antibody at the site of virus replication.
- Incidence of adverse events, serious adverse events, adverse events meeting protocol-defined DLT criteria, severe adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death. [ Time Frame: Throughout study to end of study treatment visit (Week 24 or +30 days after last study drug dose) ]Characterise the safety and tolerability of NG-350A, in combination with a check point inhibitor, by reviewing reported Adverse Events (AEs) and Serious Adverse Events (SAEs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852511
|United States, California|
|University of California, Los Angeles (UCLA)|
|Santa Monica, California, United States, 90404|
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, New York|
|Memorial Sloan Kettering Cancer Center (MSKCC)|
|New York, New York, United States, 10038|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||The University of Texas MD Anderson Cancer Center|