Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632964
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
A Clinical Trial Aimed At Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1climbing test The first dose group 21010 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 51010 IFU dose group it will transition to a conventional escalation phase using a 33 dose escalation design If no DLT occurs in 03 participants during the observation period it will escalate to the next dose if DLT occurs in 13 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 16 subjects with DLT it will proceed to the next dose group If 26 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 03 or 16 of participants during the observation period of the 101010 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 2During 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
Phase 1climbing test The first dose group 21010 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 51010 IFU dose group it will transition to a conventional escalation phase using a 33 dose escalation design If no DLT occurs in 03 participants during the observation period it will escalate to the next dose if DLT occurs in 13 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 16 subjects with DLT it will proceed to the next dose group If 26 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 03 or 16 of participants during the observation period of the 101010 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 2During 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None