A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin
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|ClinicalTrials.gov Identifier: NCT04059588|
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : March 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumor Cancer of Skin||Drug: 2141 V-11||Phase 1|
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 participants/cohort) 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of 2141-V 11 using a standard 3+3 dose-escalation design.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 16, 2020|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||July 31, 2025|
Experimental: Injection of 2141-V11
Open label study drug 2141-V11 at escalating doses until MTD is determined, and expansion utilizing the MTD.
Drug: 2141 V-11
intratumoral injection of 2141-V11
- Number of patients with treatment-emergent adverse events assessed by NCI CTCAE v4.03 [ Time Frame: through study completion, an average of 2 years ]
- Incidence and severity of DLTs reported and their relationship to 2141-V11 administration assessed by NCI CTCAE v4.03 [ Time Frame: through study completion, an average of 2 years ]
- Change from baseline laboratory assessments and toxicities over time in abnormal Complete Blood Count labs and Complete Metabolic Panel labs assessed by SI laboratory reference ranges [ Time Frame: through study completion, an average of 2 years ]
- Changes from baseline in anti-drug antibody (ADA) responses to 2141-V11 exposure over time [ Time Frame: through study completion, an average of 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059588
|Contact: Recruitment Office||1-800-782-2737||RUcares@Rockefeller.edu|
|Contact: Joseph P Colagrecco, DNP, NP-BCemail@example.com|
|Principal Investigator:||David A Knorr, MD, PhD||Rockefeller University|