Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC
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Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
70estimated
Sites
1
Country
Israel
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-01 | actual | When the study began enrolling |
| Primary completion | Aug 2025 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non Muscle Invasive Bladder Cancer
Intervention
- Drug: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel — also filed as Gemcitabine and docetaxel
Primary outcomes
what the primary-completion date above is the date OFNumber of Patients with Complete Response (CR) in High-Grade NMIBC
measured 48 weeks
Frequency and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) and Treatment-emergent AEs (TEAEs) occurring at any time during the study Serious Adverse Events (SAEs) Treatment-Emergent Adverse Events (TEAEs)
measured 48 weeks
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