Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC

Phase 2

Recruiting

• Conditions: Non Muscle Invasive Bladder Cancer
• Interventions: Drug: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel

• Registration Number: NCT06663137
• Lead Sponsor: Trigone Pharma Ltd.

Brief Summary

High-grade NMIBC is more aggressive cancer that has a higher risk of progression and recurrence compared to low-grade NMIBC. NDV01 is a novel controlled release intravesical formulation designed for the treatment of non-muscle invasive bladder cancer (NMIBC).

Detailed Description

NDV01 controlled release intravesical formulation for the treatment on refractory NMIBC. This formulation contains a combination of gemcitabine (1000 mg) and docetaxel (40 mg) and is administered directly into the bladder (intravesically). NDV01 is maximizing local drug concentration, allowing for continuous exposure of the bladder tissue to the therapeutic agents, while minimizing systemic exposure and associated side effects and , avoiding the peaks and troughs associated with conventional intravesical instillations. The combination and sustained release of the drugs improve the likelihood of eradicating cancer cells, potentially reducing the risk of recurrence. The formulation is developed as a controlled release system, allowing for the gradual release of gemcitabine and docetaxel simultaneously over 10 days period. This sustained release is critical in maintaining therapeutic drug concentrations in the bladder while reducing the frequency of administration.

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-08-08
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NDV01	NDV01 intravesical controlled release formulation of gemcitabine and docetaxel	1. Treatment phase: 6 biweekly instillations 2. Maintenance phase: monthly administration

Primary Outcome Measures

Name	Time	Method
Number of Patients with Complete Response (CR) in High-Grade NMIBC	48 weeks	Complete response is defined by at least one of the following criteria: Negative cystoscopy and negative or atypical urine cytology; and/or Positive cystoscopy with biopsy-confirmed benign or low-grade NMIBC, along with negative urine cytology.
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)	48 weeks	Any new Change from Baseline to End of Study (EOS) in investigators assessment

Secondary Outcome Measures

Name	Time	Method
Durability of Complete Response (CR) in High-Grade NMIBC	48 weeks	Evaluate how long patients maintain CR over time.
Number of Patients with CR Among Those with Carcinoma In Situ (CIS)	48 weeks	Includes those with or without co-existing high-grade Ta or T1 papillary disease.
Incidence of Event-Free Survival (EFS) at 12 Months	48 weeks	Event-free survival is defined as survival without recurrence of high-grade disease.
Durability of event-free survival in patients with high-grade Ta or T1 papillary disease (without concomitant CIS), who have no recurrence of high-grade Ta or T1 papillary disease	48 weeks	Tumor recurrence

Trial Locations

Locations (1)

Avi Gordon; 🇮🇱 Raanana, Israel