T3011 for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental treatment called T3011 to determine its effectiveness for a specific type of bladder cancer that hasn't responded to treatments like BCG or chemotherapy. The study aims to assess both the efficacy and safety of T3011 for these patients. It seeks participants with this particular type of bladder cancer who have faced challenges with previous treatments. Those whose cancer hasn't responded to BCG or chemotherapy might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you cannot take certain anti-herpes virus drugs during the study. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that T3011 is likely to be safe for humans?
Research has shown that T3011 has been safe in earlier studies. In one study, patients with bladder cancer who did not respond to BCG treatment tolerated T3011 well and did not experience severe side effects, which is encouraging.
Another study found that when T3011 was injected directly into the bladder, it did not enter the bloodstream, suggesting a lower risk of widespread side effects. Overall, these studies indicate that T3011 is safe for humans, with no major safety concerns reported so far.12345Why do researchers think this study treatment might be promising?
Most treatments for bladder cancer, like chemotherapy and immunotherapy, work by attacking cancer cells directly or boosting the overall immune response. But T3011 works differently, as it is an oncolytic virus that specifically targets and destroys cancer cells while sparing healthy ones. This precision can potentially lead to fewer side effects and improved effectiveness. Researchers are excited about T3011 because it offers a novel way to treat bladder cancer and may provide better outcomes for patients who have not responded well to standard therapies.
What evidence suggests that T3011 might be an effective treatment for bladder cancer?
Research has shown that T3011, the investigational treatment in this trial, has promising effects against bladder cancer. In studies, T3011 reduced cancer size in 25% of patients and halted disease progression in 33.3%. T3011 is an oncolytic immunotherapy, using a virus to attack cancer cells while boosting the immune system. This dual action suggests it could be effective for bladder cancer. Early safety results are positive, offering hope for those whose cancer hasn't responded to other treatments.678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Intravesical administration of Herpes Virus T3011 Injection at two dose levels to evaluate safety, tolerability, and preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- T3011
Find a Clinic Near You
Who Is Running the Clinical Trial?
ImmVira Pharma Co. Ltd
Lead Sponsor