A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).

ConditionNon-muscle Invasive Bladder Cancer (NMIBC)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorRactigen Therapeutics.

About this trial

This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily agrees to participate in this study and provides written informed consent prior to the initiation of any study-specific procedures.

Is aged ≥18 years at the time of signing the informed consent form (ICF).

Cohort A: high-risk non-muscle-invasive bladder cancer (NMIBC).

Cohort B: intermediate-risk NMIBC.

Disqualifiers

Low-risk NMIBC.

Very high-risk NMIBC.

Tumors staged as T2 or higher, or urothelial carcinoma of the upper urinary tract or urethra (renal pelvis, ureter, or urethra).

Predominantly non-urothelial histology, including squamous cell carcinoma, adenocarcinoma, or other non-urothelial carcinomas.

Trial design

Design model

Parallel

Treatments tested in this trial

RAG-01
Drug
RAG-01 is a therapeutic small activating RNA (saRNA) duplex molecule comprised of two partially chemically modified complementary oligonucleotide strands.
Chemotherapy agent
Drug
Chemotherapy agent administered in combination with RAG-01.

Treatment groups

114 Participants

are divided into 2 treatment groups

Group A: Cohort A: RAG-01 Monotherapy and CombinationExperimental treatment 2 interventions

Group B: Cohort B: RAG-01 MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Efficacy of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC)

Event-Free Survival rate

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ractigen Therapeutics.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: