drugset / Trial / NCT04781725
INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer
Phase 2
Unknown
90 enrolled
Ottawa Hospital Research Institute
Intensity Therapeutics, Inc. · collabOntario Institute for Cancer Research · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.
Timeline
- Start
- 2021-03-25
- Primary completion
- 2022-03-01
- Completion
- 2023-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2-hydroxybenzoylaminooctanoate | Unknown | 10 mg/ml | Intrathecal |
| Subject | Cisplatin | Other / unclassified | 0.5 mg/ml | Intrathecal |
| Subject | Vinblastine | Small molecule | 0.1 mg/ml | Intrathecal |