NCT06632964

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

An Open-label, Single-arm Exploratory Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer

Detailed description

The investigators designed a clinical study and divided the trial into two phases. Phase 1(climbing test): The first dose group (2×10\^10 IFU) in the ramp-up phase is the accelerated titration dose group, which will include one patient. During the observation period of dose-limiting toxicity (DLT) in the accelerated titration phase (set as 7 days after initial drug administration for each participant), if a grade 2 or higher treatment-related adverse event (TRAE) is observed, or when escalating to the second dose group (5×10\^10 IFU dose group), it will transition to a conventional escalation phase using a 3+3 dose escalation design: If no DLT occurs in 0/3 participants during the observation period, it will escalate to the next dose; if DLT occurs in 1/3 participants during the observation period, an additional three participants will be enrolled at this dosage level simultaneously. If no DLT occurs among these additional three participants during their observation period (total of 1/6 subjects with DLT), it will proceed to the next dose group. If ≥2/6 participants experience DLT, then the ramp-up trial will terminate and a lower dosage level below current level will be selected for dosing expansion stage. Alternatively, based on existing clinical data, the investigators may redefine ramp-up doses. If no DLT occurs in 0/3 or 1/6 of participants during the observation period of the 10×10\^10 IFU dose group, the investigators determine whether to continue increasing ramp-up doses and ultimately determine dosages for expansion stage based on exploration results from ramp-up phase. Participants who do not experience DLT during ramp-up phase can continue receiving study drug at same dosage via intravesical instillation once weekly for six consecutive weeks (including initial administration). Subsequent administration is determined by the investigators monthly and should not exceed one year unless disease progression or recurrence occurs, intolerable toxicity develops, participant withdraws informed consent or dies, the investigator deems continued treatment inappropriate or other termination criteria are met according to earliest. Phase 2:During the expansion phase, approximately 8-10 participant will be enrolled based on the recommended dose from the escalation phase. The number of participant may be adjusted by the investigators based on existing trial data, and non-resectable high-risk and very high-risk NMIBC patients may also be included in the expansion phase study. The dosing plan for the expansion phase is as follows: multiple administrations once a week through intravesical instillation for six consecutive weeks. Subsequent administration frequency will be determined by the investigators (once a month, up to a maximum of one year) or until disease progression or recurrence occurs, intolerable toxicity arises, participant withdraws informed consent or dies, the investigator deems it inappropriate to continue treatment, or other termination criteria are met with priority given to events occurring first. Dose-Limiting Toxicity (DLT) is defined as an event related to the investigational drug that meets any of the following criteria during the observation period: 1. Any toxicity ≥ Grade 3 except for fatigue lasting ≤3 days or fatigue and weakness that can be relieved through rest or self-adjustment; clinically insignificant reversible laboratory abnormalities ≥ Grade 3. 2. Any toxicity that cannot recover to ≤ Grade 1 baseline level within seven days after discontinuation of dosing.

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant oncolytic adenovirus injection solution of VT-101	Active ingredient: VT-101 recombinant oncolytic adenovirus Specifications: 2×10\^10 IFU/ml, 0.5ml/ capsule Method of administration: intravesical perfusion

Timeline

• Start date: 2024-09-18
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: China