Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
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|ClinicalTrials.gov Identifier: NCT04025307|
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : March 31, 2020
This study is as an open-label study to be conducted at multiple study centres across New Zealand and Australia designed to characterise the safety, tolerability and preliminary assessment of the anti-tumour efficacy of bacTRL-IL-12 after intravenous (IV) infusion.
The study will consist of a screening period (Day -14 to Day -2), treatment and observation (Day 1 to Day 22), safety follow-up period (Day 28 to Day 31), and efficacy follow-up period (until progression, death, revocation of consent, or lost to follow-up).
|Condition or disease||Intervention/treatment||Phase|
|Cancer - Solid Tumours||Drug: bacTRL-IL-12||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-centre, Open-label, Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours|
|Actual Study Start Date :||August 5, 2019|
|Estimated Primary Completion Date :||March 11, 2021|
|Estimated Study Completion Date :||March 11, 2021|
single-dose, 1 mL IV infusion of bacTRL-IL-12
bacTRL-IL-12 is a live, genetically modified Bifidobacterium longum (B longum), for administration via IV infusion. The probiotic bacteria selectively colonize solid tumour tissues and are engineered to deliver genetic material encoding the pro-inflammatory transgene Interleukin-12 (IL-12). Plasmid DNA encoding the IL-12 transgene is delivered to the patient's cells within the tumor microenvironment, whereupon IL-12 is expressed to stimulate local and systemic anti-tumour immune responses.
- Incidence and severity of adverse events according to NCI CTCAE [ Time Frame: day 31 safety follow up ]
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): NCT04025307
|Contact: Rebecca Ho||+61 434 563 email@example.com|
|Contact: Michelle Jonesfirstname.lastname@example.org|
|Monash Medical Centre||Recruiting|
|Contact: Karen Gillett|