drugset / Trial / NCT04025307

Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours

NCT04025307 ↗

Phase 1 Terminated 5 enrolled IQVIA Pty Ltd
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2019-08-05
Primary completion
2020-12-29
Completion
2020-12-29

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject bacTRL-IL-12 Unknown 1 ml Intravenous

Indications

No indication recorded.