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

NCT06351904 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Non-Muscle-Invasive Bladder Cancer (NMIBC)

Interventions

DRUG

RAG-01

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

Sponsors & Collaborators

  • Ractigen Therapeutics.

    lead OTHER

Principal Investigators

  • Laurence Krieger, MBCHB · GenesisCare, 7 Westbourne Street, St Leonards, NSW 2065, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351904 on ClinicalTrials.gov