Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549465
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Study Evaluating Dosimetry Randomized Dose Optimization Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-label Study Evaluating Dosimetry Randomized Dose Optimization Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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 a three-part study evaluating the safety and efficacy of a PSMA-directed radioantibody rosopatamab tetraxetan conjugated to either In-111 or Ac-225 Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions Participants then will be enrolled into either Part 2 Dose Optimization or Part 3 Dose Escalation depending on their prior treatment history Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle dose administration on Day 1 and Day 15 at either 55 or 60 KBqKg Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45 55 or 60 KBqKg Dose limiting toxicities DLTs will be monitored in Part 3 to determine the recommended phase 2 dose RP2D and the study may enroll additional participants to be treated with the RP2D dose level Participants enrolled into any part will attend study visits which will include blood samples electrocardiogram ECG radiographic imaging and physical examinations along with other assessments
Detailed Description:
None
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