Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639191
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
177LuLu-AKIR001 First-in-human Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Prospective Open-label First-in-human Study to Evaluate the Safety Tolerability and Biodistribution of 177LuLu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours
Status:
NOT_YET_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:
AKIR001
Brief Summary:
The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of 177LuLu-AKIR001 both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available The main question it aims to answer is
What is the toxicity profile of the study drug 177LuLu-AKIR001 according to the rate of Dose Limiting Toxicities and Severe Adverse Events Participants will receive one 177LuLu-AKIR001 infusion followed by a 6-week safety follow-up period which can be extended up to 12 weeks Possible additional infusions of the trial drug up to a maximum number of four can be given when clinical benefit is noted and toxicity is deemed acceptable
What is the toxicity profile of the study drug 177LuLu-AKIR001 according to the rate of Dose Limiting Toxicities and Severe Adverse Events Participants will receive one 177LuLu-AKIR001 infusion followed by a 6-week safety follow-up period which can be extended up to 12 weeks Possible additional infusions of the trial drug up to a maximum number of four can be given when clinical benefit is noted and toxicity is deemed acceptable
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