T3011 for Bladder Cancer

Overseen By Jasmine Yang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ImmVira Pharma Co. Ltd

Must not be taking: Anti-herpes drugs

Disqualifiers: Muscle-invasive cancer, Brain metastasis, Cardiovascular diseases, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-arm, open-label, multicenter, phase II clinical study to evaluate the tolerability, safety, and preliminary efficacy of intravesical administration of Herpes Virus T3011 Injection in participants with BCG-unresponsive high risk non-muscle-invasive bladder cancer (NMIBC) .

Eligibility Criteria

This trial is for adults over 18 with high risk non-muscle-invasive bladder cancer that doesn't respond to BCG therapy. They should have an expected survival of at least 24 weeks, be able to undergo specific tests, and not have had certain cancers or major surgeries recently. Participants must not be pregnant or breastfeeding and agree to use contraception.

Inclusion Criteria

Expected survival ≥24 weeks

Participants must voluntarily comply with the study-specified cystoscopy, urine cytology and randomized biopsy

Laboratory test values meeting specified requirements

Exclusion Criteria

I had bladder cancer in the upper urinary tract or prostatic urethra in the last 2 years.

I have or had bladder cancer that has spread or was invasive.

History of allergic reactions to specific components

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intravesical administration of Herpes Virus T3011 Injection at two dose levels to evaluate safety, tolerability, and preliminary efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• T3011

Trial Overview The study is testing the safety and effectiveness of T3011, a herpes virus injection given directly into the bladder. It's a phase II trial where all participants receive T3011 without being compared to another treatment.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

T3011

Who Is Running the Clinical Trial?

ImmVira Pharma Co. Ltd

Lead Sponsor

Trials

6

Recruited

530+