First in Human Study With NG-641, an Oncolytic Transgene Expressing Adenoviral Vector
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|ClinicalTrials.gov Identifier: NCT04053283|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : November 9, 2021
|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 Ia part of the study is a dose escalation and dose expansion phase investigating NG-641 administration by intratumorural injection (IT) and intravenous (IV) infusion in a range of tumour types
The Phase Ib part of the study is to investigate safety and efficacy of NG-641 as monotherapy or in combination with chemotherapy agents and/or checkpoint inhibitors in separate efficacy cohorts of patients with specific epithelial tumour types.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, an Oncolytic 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, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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, Day 85 ]Assess the safety and tolerability of NG-641 by review of adverse events including serious adverse events (SAEs), 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.
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: PsiOxus Therapeutics||+44 email@example.com|
|Contact: PsiOxus Therapeutics||+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, Louisiana|
|Ochsner Medical Center (OMC) - The Gayle and Tom Benson Cancer Center||Active, not recruiting|
|New Orleans, Louisiana, United States, 70121-2429|
|United States, Missouri|
|Washington University Medical School||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Brooke Fenwick 314-362-6470 firstname.lastname@example.org|
|Principal Investigator: Haeseong Park|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Contact: Samantha Berkey 713-792-5560 SCBerkey@mdanderson.org|
|Principal Investigator: Vivek Subbiah|
|Principal Investigator:||Haesong Park, MD||Washington University School of Medicine, St Louis, Missouri|