A Phase I Intravesical PPM Therapy for NMIBC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT05519241
Phase
PHASE1
Status
Recruiting
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Conditions

  • Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PLZ4-coated paclitaxel-loaded micelles (PPM) — DRUG
    PPM will be administrated weekly for 6 times through intravesical instillation into the bladder cavity

Study Details

This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill bladder cancer cells. In this trial, PPM will be instilled into the bladder cavity to treat bladder cancer that does not invade into the muscle layer of the bladder and that has failed the treatment of another drug BCG. Up to 29 patients will be enrolled into the trial. The main goal of this trial is to determine the dose of PPM for future clinical trials, assess the toxicity and obtain preliminary data regarding its effectiveness.

Key Dates

Start date
Oct 10, 2022
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I dose-escalation and expansion cohort
    There are three doses at the dose escalation stage: Dose level I: paclitaxel (PTX) 25 mg or 0.5 mg/ml; Dose Level II: PTX 50 mg or 1.0 mg/ml; Dose Level III: PTX 75 mg or 1.5 mg/ml. At the expansion cohort, up to 12 patients will be recruited and treated with PPM at the PTX dose of 50 mg or 1.0 mg/ml to determine the efficacy.

Primary Outcome Measure

adverse events [ Time Frame: up to 6 weeks after the last dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Chong-Xian Pan, MD PhD
[email protected]
857-203-6189
Chong-Xian Pan, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MA

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