Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531499
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
A Study of Radiation Dosimetry Safety and Tolerability of Extended Lutetium 177Lu Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer RADIOpharmaceutical DOSimetry Evaluation RADIODOSE Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-label Multi-center Study of Radiation Dosimetry Safety and Tolerability of Extended Lutetium 177Lu Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
RADIODOSE
Brief Summary:
The purpose of the study is to assess and evaluate dosimetry safety and tolerability following administration of up to 12 cycles of 177Lu vipivotide tetraxetan also referred to as 177LuLu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617 in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment eGFR 60mlmin
Detailed Description:
The study includes screening period treatment period and a post-treatment follow-up period
Screening Period Approximately 106 participants will be enrolled to receive up to12 consecutive cycles of AAA617 Potential participants will be assessed for eligibility by verifying their baseline PSMA PET scan for mandatory confirmation of PSMA positivity prior to first cycle by local review
Treatment Period Eligible participants will be treated with up to 12 cycles of 74 GBq AAA617 intravenously every 6 weeks until radiographic progression toxicity leading to treatment discontinuation death loss to follow-up or withdrawal of consent whichever occurs first During treatment period all participants who complete the initial 6 cycles of AAA617 treatment will undergo an additional PSMA-PET scan after Cycle 6 to re-assess PSMA expression level and to reassess eligibility of participants to receive additional AAA617 treatment cycles
Post-Treatment Follow-Up All participants will undergo a PSMA-PET scan at end of treatment EOT The post-treatment follow-up period will consist of EOT 42-days safety EOT RLI safety survival and rPFS follow-up visits
The planned duration of treatment period is up to 74 weeks with treatment given every 6 weeks Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression andor at the discretion of the Investigator or the participant
Screening Period Approximately 106 participants will be enrolled to receive up to12 consecutive cycles of AAA617 Potential participants will be assessed for eligibility by verifying their baseline PSMA PET scan for mandatory confirmation of PSMA positivity prior to first cycle by local review
Treatment Period Eligible participants will be treated with up to 12 cycles of 74 GBq AAA617 intravenously every 6 weeks until radiographic progression toxicity leading to treatment discontinuation death loss to follow-up or withdrawal of consent whichever occurs first During treatment period all participants who complete the initial 6 cycles of AAA617 treatment will undergo an additional PSMA-PET scan after Cycle 6 to re-assess PSMA expression level and to reassess eligibility of participants to receive additional AAA617 treatment cycles
Post-Treatment Follow-Up All participants will undergo a PSMA-PET scan at end of treatment EOT The post-treatment follow-up period will consist of EOT 42-days safety EOT RLI safety survival and rPFS follow-up visits
The planned duration of treatment period is up to 74 weeks with treatment given every 6 weeks Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression andor at the discretion of the Investigator or the participant
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