TARA-002 for Bladder Cancer
(ADVANCED-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TARA-002 for individuals with high-grade CIS NMIBC, a type of bladder cancer. The goal is to assess the safety and effectiveness of TARA-002 in fighting tumors when introduced directly into the bladder. Participants will be divided into two groups: those who have never received the common bladder treatment BCG, or haven't received it for at least two years, and those whose cancer did not respond to BCG within a year. Suitable candidates have active non-muscle invasive bladder cancer and a history of poor response to other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that TARA-002 is likely to be safe for humans?
Previous studies have shown that TARA-002 is well tolerated by patients. For instance, research found that TARA-002 was generally safe, with most patients not experiencing severe side effects. Another study reported a high success rate in treating bladder cancer, with 72% of patients showing a complete response at six months. This suggests that TARA-002 is effective and does not cause major issues for most people. While no treatment is without risks, the data so far appears promising in terms of safety.12345
Why do researchers think this study treatment might be promising for bladder cancer?
Most treatments for bladder cancer, like chemotherapy and immunotherapy, work by attacking cancer cells or boosting the immune system to fight cancer. TARA-002 is unique because it uses a lyophilized biological preparation derived from Streptococcus pyogenes cells. Researchers are excited about TARA-002 because it offers a new mechanism of action by potentially stimulating the immune system differently and may provide an alternative for patients who do not respond well to traditional therapies. This innovative approach could lead to more effective treatments with potentially fewer side effects.
What evidence suggests that TARA-002 might be an effective treatment for bladder cancer?
Research has shown that TARA-002, the investigational treatment in this trial, offers promising results for treating non-muscle invasive bladder cancer (NMIBC). In earlier studies, 70% of patients experienced a complete response, meaning their cancer disappeared. After six months, 72% of these patients still showed no signs of cancer. The treatment works well for patients from various backgrounds, including those who have previously received BCG, a common bladder cancer treatment. Overall, TARA-002 appears to be a well-tolerated and effective option for this type of bladder cancer.13567
Who Is on the Research Team?
Chief Scientific Operations Officer
Principal Investigator
Protara Therapeutics
Are You a Good Fit for This Trial?
Adults over 18 with high-grade non-muscle invasive bladder cancer who can't get BCG therapy or haven't had it in the last 24 months, or those not responding to BCG after adequate treatment. Excluded are those with certain types of bladder cancer, a history of more advanced cancer, penicillin allergy, and nodal/metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravesical instillation of TARA-002 to assess safety and anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TARA-002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Protara Therapeutics
Lead Sponsor