Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504942
Status:
UNKNOWN
Last Update Posted:
2022-07-01
First Post:
2020-06-10
Brief Title:
Basket Study of Leronlimab PRO 140 in Patients With CCR5 Locally Advanced or Metastatic Solid Tumors
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
Basket Study of Leronlimab PRO 140 in Patients With CCR5 Locally Advanced or Metastatic Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 single arm phase II study with 30 patients of leronlimab PRO 140 in patients with CCR5 locally advanced or metastatic solid tumors
Leronlimab PRO 140 will be administered subcutaneously as weekly dose of 525 mg until disease progression or intolerable toxicity Subjects participating in this study will be allowed to receivecontinue standard-of-care chemotherapy or radotherapy as per the dosing schedule included on the package insert
In this study patients will be evaluated for tumor response approximately every 3 months or according to institutions standard practice by CT PETCT or MRI with contrast per treating investigators discretion using the same method as at baseline
Leronlimab PRO 140 will be administered subcutaneously as weekly dose of 525 mg until disease progression or intolerable toxicity Subjects participating in this study will be allowed to receivecontinue standard-of-care chemotherapy or radotherapy as per the dosing schedule included on the package insert
In this study patients will be evaluated for tumor response approximately every 3 months or according to institutions standard practice by CT PETCT or MRI with contrast per treating investigators discretion using the same method as at baseline
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?:
False
Is an FDA AA801 Violation?:
None