Open-Label Phase 1 Study to Evaluate Safety and Effectiveness of VT-101 Given by Bladder Instillation for Non-Muscle Invasive Bladder Cancer in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating VT-101, an experimental recombinant oncolytic adenovirus therapy, for treating non-muscle invasive bladder cancer NMIBC. This open-label, single-arm exploratory phase 1 clinical trial aims to assess the safety and efficacy of VT-101 in patients with moderate to very high-risk NMIBC, including those who may be medically unfit or refuse standard surgeries. The study is sponsored by The Affiliated Hospital of Xuzhou Medical University. The trial is divided into two phases. Phase 1 uses an accelerated titration dose escalation design starting with a low dose, increasing doses cautiously while monitoring for dose-limiting toxicities DLT over 7-day periods. Participants who tolerate the doses receive weekly intravesical instillations for six weeks, with possible monthly maintenance dosing up to one year unless progression, toxicity, withdrawal, or other criteria occur. Phase 2 expands enrollment based on the recommended dose from phase 1, including patients with unresectable high-risk NMIBC, following a similar dosing schedule. Participants undergo regular evaluations including cystoscopy, urine cytology, urography, and biopsy as needed. Researchers will monitor adverse events, treatment discontinuations due to toxicity, and tumor response rates such as complete or partial response and disease progression. Safety and efficacy are primarily assessed three months after treatment. The total participation time depends on treatment continuation and follow-up requirements, with careful safety monitoring throughout the study.

A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer