Study of oral TherO2-01S22 with anti-HER2 therapy in patients with metastatic breast cancer
Not yet recruitingStudy of oral TherO2-01S22 with anti-HER2 therapy in patients with metastatic breast cancer
- Participants:Adults
Rare diseases
Investigational molecules
Locations
Inositol trispyrophosphate hexasodium (ITPP) is a chemically synthesised substance. It is an investigational substance with no marketing authorisation in the product records.[1] In the registered trials it appears under the product name OXY111A when given by infusion, and as TherO2-01S22 when given by mouth.[2] The substance is supplied by the Wojskowy Instytut Medyczny–Państwowy Instytut Badawczy.[1]
The registry records do not describe a molecular target or mechanism of action for inositol trispyrophosphate hexasodium. The Phase 2 trial describes it as an adjunctive treatment intended to improve respiratory capacity in progressive respiratory failure, measured by gasometric and biochemical parameters.[1]
In the Phase 2 trial, inositol trispyrophosphate hexasodium (OXY111A) was given as a solution for infusion by intravenous use at a dose of 5 grams.[1] In the breast cancer trial, an oral form (TherO2-01S22) was given at a dose of 6 grams.[2]
Two interventional trials are registered for inositol trispyrophosphate hexasodium. One is a completed Phase 2 trial in 100 participants with COVID-19 and other pulmonary parenchymal infections.[1] The other is an authorised Phase 4 trial planning to enrol 224 participants with metastatic breast cancer.[2]
The Phase 2 trial measured improvement of respiratory capacity through gasometric and biochemical parameters.[1] The Phase 4 trial measures the objective response rate (ORR), which is the percentage of patients whose disease decreases or disappears after treatment, assessed by RECIST V1.1 criteria and PET scan.[2]
The Phase 2 trial enrolled patients with progressive respiratory failure due to COVID-19 or other pulmonary parenchymal infections.[1] The Phase 4 trial enrols patients with metastatic breast cancer receiving first-line anti-HER2 targeted treatment.[2]
No side effect information is provided in the registry records for inositol trispyrophosphate hexasodium.
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