Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04635995|
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : April 5, 2022
LVGN7409 is a humanized monoclonal antibody that specifically binds to CD40, and acts as an agonist against CD40.
This first in human study of LVGN7409 is designed to establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN7409, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody and/or CD137 agonist in the treatment of advanced or metastatic malignancy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: LVGN7409||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, First in Human (FIH), Phase 1a/1b Trial of LVGN7409 (CD40 Agonist Antibody) as a Single Agent, in Combination With LVGN3616 (Anti-PD-1 Antibody), and in Combination With LVGN3616 and LVGN6051 (CD137 Agonist Antibody) in Patients With Locally Advanced, Relapsed, Refractory, or Metastatic Malignancy|
|Actual Study Start Date :||December 11, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||April 2023|
Experimental: Monotherapy dose escalation
The monotherapy dose escalation phase includes 8 dose levels of LVGN7409. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). One cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
IV infusion once every 3 weeks (Q3W).
- Treatment-emergent adverse events (TEAEs) [ Time Frame: up to 24 months ]determination of DLTs and serious AEs (SAEs) of LVGN7409 as monotherapy. Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- RP2D of LVGN7409 as monotherapy [ Time Frame: up to 24 months ]determination of MTD, RDE and/or RP2D of LVGN7409 as monotherapy
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): NCT04635995
|Contact: Lynn Jiang, PhDemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030-3722|
|Contact: Yi-Hsin Hsu, PhD 713-794-3601 YHsu1@mdanderson.org|