drugset / Trial / NCT04025307
Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bacTRL-IL-12 | Unknown | 1 ml | Intravenous |
Indications
No indication recorded.