Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05477576
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2022-07-20
Brief Title:
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Sponsor:
RayzeBio Inc
Organization:
RayzeBio Inc
Study Overview
Official Title:
Phase 1b3 Global Randomized Controlled Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable Advanced SSTR Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTION-1
Brief Summary:
This study aims to determine the safety pharmacokinetics PK and recommended Phase 3 dose RP3D of RYZ101 in Part 1 and the safety efficacy and PK of RYZ101 compared with investigator-selected standard of care SoC therapy in Part 2 in subjects with inoperable advanced well-differentiated somatostatin receptor expressing SSTR gastroenteropancreatic neuroendocrine tumors GEP-NETs that have progressed following treatment with Lutetium 177-labelled somatostatin analogue 177Lu-SSA therapy such as 177Lu-DOTATATE or 177Lu-DOTATOC 177Lu-DOTATATETOC or 177Lu-high affinity HA-DOTATATE
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None