Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03746431
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2018-11-09
Brief Title:
A Phase 12 Study of 225Ac-FPI-1434 Injection
Sponsor:
Fusion Pharmaceuticals Inc
Organization:
Fusion Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 12 Study of 225Ac-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This is a first-in-human Phase 12 non-randomized multi-centre open-label clinical study designed to investigate safety tolerability PK and preliminary anti-tumour activity of 225Ac-FPI-1434 radioimmuno-therapeutic agent in patients with solid tumours that demonstrate uptake of 111In-FPI-1547 radioimmuno-imaging agent and to establish the maximum tolerated dose MTD andor the recommended Phase 2 dose RP2D of repeat doses of 225Ac-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of 111In-FPI-1547 radioimmuno-imaging agent
Detailed Description:
This study consists of a Phase 1 portion and a Phase 2 portion
Phase 1 includes the following cohorts Single dose-ascending cohorts and Multi- dose ascending cohorts of 225Ac-FPI-1434 and Multi- dose ascending cohorts evaluating administration of FPI-1175 cold antibody followed by 225Ac-FPI-1434 cold hot with cycles repeating every 42 days And Cold Antibody Sub-study evaluating administration of ascending doses of FPI-1175 followed by 111In-FPI-1547
The Phase 2 will evaluate 111In-FPI-1547 and 225Ac-FPI-1434 with or without FPI-1175 in tumour-specific cohorts The decision to utilize FPI-1175 in the Phase 2 portion of the study will be determined based on Phase 1 data including safety tolerability pharmacokinetic and dosimetry results
Phase 1 includes the following cohorts Single dose-ascending cohorts and Multi- dose ascending cohorts of 225Ac-FPI-1434 and Multi- dose ascending cohorts evaluating administration of FPI-1175 cold antibody followed by 225Ac-FPI-1434 cold hot with cycles repeating every 42 days And Cold Antibody Sub-study evaluating administration of ascending doses of FPI-1175 followed by 111In-FPI-1547
The Phase 2 will evaluate 111In-FPI-1547 and 225Ac-FPI-1434 with or without FPI-1175 in tumour-specific cohorts The decision to utilize FPI-1175 in the Phase 2 portion of the study will be determined based on Phase 1 data including safety tolerability pharmacokinetic and dosimetry results
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