First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector (STAR)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04053283|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : January 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Epithelial Tumor||Biological: NG-641||Phase 1|
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types.
The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)|
|Actual Study Start Date :||January 23, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
In the IV cohort, patients will receive a single cycle of study treatment, with three single doses of NG-641 on Days 1, 3 and 5 by IV infusion.
NG-641 is an oncolytic adenoviral vector which expresses a FAP-TAc antibody together with an immune enhancer module (CXCL9/CXCL10/IFNα).
- Incidence of adverse events (safety and tolerability) in study NG-641 [ Time Frame: End of study treatment visit ]Incidence of adverse events, adverse events meeting protocol-defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
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): NCT04053283
|Contact: Akamis Bio||+44 email@example.com|
|Contact: Akamis Bio||+44 firstname.lastname@example.org|
|United States, California|
|University of Southern California (USC) - Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Gloria Bryant 323-865-3967 Gloria.Bryant@med.usc.edu|
|Principal Investigator: Heinz-Josef Lenz|
|Santa Barbara, California, United States, 93105|
|Contact: Rose Estrada email@example.com|
|Principal Investigator: Lee Rosen|
|United States, Florida|
|Moffitt-Advent Health Clinical Research Unit||Recruiting|
|Celebration, Florida, United States, 34747|
|Contact: Felipe Valerio 321-460-3580 Felipe.Valerio@AdventHealth.com|
|Principal Investigator: George Simon|
|United States, Louisiana|
|Ochsner Medical Center (OMC) - The Gayle and Tom Benson Cancer Center||Completed|
|New Orleans, Louisiana, United States, 70121-2429|
|United States, Missouri|
|Washington University Medical School||Active, not recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|MD Anderson||Active, not recruiting|
|Houston, Texas, United States, 77030|