Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04059588
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2019-08-07
Brief Title:
A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
A Phase I Dose-escalation Study Investigating the Safety and Tolerability of Intratumoral Injection of an Fc-engineered Anti-CD40 Monoclonal Antibody 2141-V11 in Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The purpose of this study is to test the safety and tolerability of 2141-V11 in people who have cancer that does not respond to standard treatment and who have skin lesions skin tumors associated with their cancer The study will also test how the body processes and responds to 2141-V11 and if the study drug has cancer fighting activity in people The study drug activates a naturally occurring protein called CD40 By activating CD40 cells of the immune system are better able to identify and kill cancer cells
We are testing if injection of 2141-V11 into metastasis to the skin will be safe and well tolerated and may result in immune activation in patients with solid tumors that have metastasis to the skin
We are testing if injection of 2141-V11 into metastasis to the skin will be safe and well tolerated and may result in immune activation in patients with solid tumors that have metastasis to the skin
Detailed Description:
This is a Phase 1 open label dose-escalation study evaluating the safety pharmacokinetics pharmacodynamics immunogenicity and efficacy of the Fc-engineered variant 2141-V11 in patients with previously treated relapsed or refractory solid tumors and locally advanced or metastatic solid tumors to the skin amenable to intratumoral injection
There are two parts to the study a dose-finding stage Part I and a dose expansion stage Part II Both Part I and Part II of the study will include patients with locally advanced or metastatic cancers of the skin which are not amenable to standard treatment
A traditional 3 3 dose escalation design will be used Part I Successive cohorts of participants 3 participantscohort will be started on a fixed dose intratumoral injection of 2141V11 at the dose assigned to their cohort The study drug 2141-V11 will be dosed once every 3 weeks The study drug is administered in cycles
The first group of study participants in Part I will receive the lowest dose of study drug The next group of study participants will receive the next higher dose This dosing scheme continues until the maximum tolerated dose is determined The maximum tolerated dose MTD will be defined as 1 dose level below the dose in which DLTs are observed in 33 of the participants
Participants in Part II of the study will receive the MTD determined from Part 1 dose escalation of the study Part II participants in the study will also receive two vaccinations KLH and tetanus to allow monitoring of their immune function
Participants in both Part I and II can continue to receive cycles of study drug at their assigned dose if they do not experience progression of disease a serious adverse event and the study is ongoing
There are two parts to the study a dose-finding stage Part I and a dose expansion stage Part II Both Part I and Part II of the study will include patients with locally advanced or metastatic cancers of the skin which are not amenable to standard treatment
A traditional 3 3 dose escalation design will be used Part I Successive cohorts of participants 3 participantscohort will be started on a fixed dose intratumoral injection of 2141V11 at the dose assigned to their cohort The study drug 2141-V11 will be dosed once every 3 weeks The study drug is administered in cycles
The first group of study participants in Part I will receive the lowest dose of study drug The next group of study participants will receive the next higher dose This dosing scheme continues until the maximum tolerated dose is determined The maximum tolerated dose MTD will be defined as 1 dose level below the dose in which DLTs are observed in 33 of the participants
Participants in Part II of the study will receive the MTD determined from Part 1 dose escalation of the study Part II participants in the study will also receive two vaccinations KLH and tetanus to allow monitoring of their immune function
Participants in both Part I and II can continue to receive cycles of study drug at their assigned dose if they do not experience progression of disease a serious adverse event and the study is ongoing
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