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

NCT06663137 | Recruiting Phase 2 DMC

• 1 other identifier: REL-NDV01-011
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.

Conditions

Non Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Patients with Complete Response (CR) in High-Grade NMIBC

  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.

  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)

  Any new Change from Baseline to End of Study (EOS) in investigators assessment

  48 weeks

Secondary Outcomes (4)

• Durability of Complete Response (CR) in High-Grade NMIBC

  48 weeks

• Number of Patients with CR Among Those with Carcinoma In Situ (CIS)

  48 weeks

• Incidence of Event-Free Survival (EFS) at 12 Months

  48 weeks

• 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

Other Outcomes (1)

• Pharmacokinetic parameters of NDV01 KIT will be evaluated

  20 weeks

Study Arms (1)

NDV01

EXPERIMENTAL

1. Treatment phase: 6 biweekly instillations - six instillations on Days 1, 14, 28, 42, 56, and 70 2. Maintenance phase: monthly administration - maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340 A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule.

Drug: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel

Interventions

NDV01 intravesical controlled release formulation of gemcitabine and docetaxel DRUG

NDV01 is administered intravesically using a catheter.

Also known as: Gemcitabine and docetaxel

NDV01

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 - 80 years old
• Able to give informed consent
• Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression.
• Participants must be ineligible for or have elected not to undergo radical cystectomy.
• Available for the whole duration of the study.
• Life expectancy \>2 years, in the opinion of the investigator.
• Eastern Cooperative Oncology Group (ECOG) status 2 or less.
• Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or MRI with or without urogram performed within 6 months of enrolment.
• Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies.

You may not qualify if:

• Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic disease are (but not limited to):
• Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample.
• Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion..
• Current systemic therapy for bladder cancer.
• Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).
• Clinically significant and unexplained elevated liver or renal function tests.
• Women who are pregnant or lactating or refuse to commit to using contraception anytime during the study.
• Any other significant disease or other clinical findings which in the investigator's opinion would prevent study entry.
• History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24 months after nephroureterectomy.

Sponsors & Collaborators

• Relmada Therapeutics, Inc.: lead

Study Sites (1)

Relmada Site

Raanana, 4363007, Israel

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Boris Chertin

  Head of Urology Dep Share Tzedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Greene

CONTACT

+15129691739; pgreene@relmada.com

Scott White

CONTACT

+16464285264; swhite@relmada.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: October 29, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)