Study on T3011 for Patients with High-Risk Bladder Cancer Not Responding to BCG Treatment

Sponsor: ImmVira Pharma Co. Ltd

Sponsor score: 0

ClinicalTrials ID:NCT06971614

Provider View

This clinical trial is testing a new treatment called T3011 for patients with high-risk bladder cancer that has not responded to BCG therapy. The study aims to evaluate the safety and effectiveness of T3011 when administered directly into the bladder.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new treatment, T3011, for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) that has not responded to BCG treatment. T3011 is given directly into the bladder in two different doses to find the best dose for future studies. The trial will involve 15-30 participants initially, with more participants added once the best dose is determined.

Description

This Phase II study is testing the safety and effectiveness of T3011, a new treatment for high-risk bladder cancer that hasn't responded to BCG therapy. T3011 is administered directly into the bladder in a liquid form. Two different doses will be tested: a lower dose and a higher dose. Initially, 15-30 participants will receive these doses to determine the best one for further testing. Once the best dose is identified, at least 40 more participants will receive this dose to further evaluate its safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-muscle-invasive bladder cancer (NMIBC).
  • Agree to undergo specific tests and procedures during the study, such as cystoscopy and urine tests.
  • Any side effects from previous cancer treatments must have improved to a mild level.
  • Be in good overall health with a performance status score of 0-2.
  • Expected to live at least 24 more weeks.
  • Have adequate blood counts and organ function based on specific lab tests.
  • Women of childbearing potential must test negative for pregnancy and agree to use effective birth control during the study and for 6 months after.
  • Men must agree to use effective birth control and not donate sperm during the study and for 6 months after.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Have a history of muscle-invasive or metastatic bladder cancer.
  • Have had cancer in the upper urinary tract or prostate within the last 2 years.
  • Have received certain cancer treatments within 4 weeks before the study.
  • Plan to receive other cancer treatments during the study.
  • Have allergies to components of the T3011 treatment.
  • Have a history of brain metastasis or certain other serious conditions.
  • Have other active cancers or serious heart conditions.
  • Have certain immune disorders or require immunosuppressive treatment.
  • Have a fever over 38.5°C that is not related to cancer.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have had a splenectomy or organ transplant.
  • Have used oncolytic virus treatments before.
  • Require certain anti-herpes medications during the study.
  • Have psychiatric disorders affecting study compliance.
  • Have a history of substance abuse within the last year.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have received a live vaccine within 4 weeks before the study.
  • Have had major surgery recently.
  • Have any other conditions that might interfere with the study or make participation unsafe.

Locations

FACILITYZIPCITYSTATE
Advanced Urology Medical Offices90045Los AngelsCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.