NCT04781725

INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer

A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoral INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

The study comprises 2 consecutive parts. The first part will be to test safety and feasibility of the dosing procedures. Results from Part I of the study will standardise the optimal dose and frequency of INT230-6 for participants in Part II. Part I: Open-label 2:1 randomized study of up to 30 patients. Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery, at a dose based on longest diameter. The control arm patients receive no treatment. Part II: Double-blind, 2:1 randomized study of up to an additional 60 patients. The placebo arm includes a saline injection of similar dose and frequency as the treatment arm (up to 2 doses of INT230-6/saline injected weekly prior to breast surgery).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	INT230-6	INT230-6 is a formulation of two well known chemotherapeutic agents, cisplatin (0.5mg/mL) and vinblastine sulfate (0.1mg/mL), combined with 2-hydroxybenzoylaminooctanoate (also known as SHAO-FA or SHAO as a sodium salt at 10mg/mL).
OTHER	Saline injection	Standard 0.9 % NaCl Normal Saline

Timeline

• Start date: 2021-03-25
• Primary completion: 2022-03-01
• Completion: 2023-03-01
• First posted: 2021-03-04
• Last updated: 2021-11-17

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study