RecruitingPhase 1NCT06351904

A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy

A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy


Sponsor

Ractigen Therapeutics.

Enrollment

72 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called RAG-01 — delivered directly into the bladder via a catheter — for people with high-grade non-muscle-invasive bladder cancer (NMIBC) whose cancer came back or did not respond after treatment with BCG (a standard bladder cancer immunotherapy). **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-grade non-muscle-invasive bladder cancer - Your cancer did not respond to or came back after BCG treatment - Your expected survival is at least 6 months - Your blood counts and organ function (liver, kidneys) meet minimum requirements - You are able to tolerate a catheter placed into the bladder **You may NOT be eligible if...** - Your bladder cancer has invaded the muscle wall or spread outside the bladder - You have serious kidney, liver, or blood problems - You have active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRAG-01

RAG-01 is a therapeutic small activating RNA (saRNA) duplex molecule comprised of two partially chemically modified complementary oligonucleotide strands.


Locations(3)

GenesisCare North Shore

St Leonards, New South Wales, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Peninsula & South Eastern Haematology and Oncology Group

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06351904


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