Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy
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|ClinicalTrials.gov Identifier: NCT04130542|
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : March 19, 2021
LVGN6051 is a humanized monoclonal antibody that specifically binds to CD137, and acts as an agonist against CD137.
This first in human study of LVGN6051 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 LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab/MK-3475) in the treatment of advanced or metastatic malignancy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: LVGN6051||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, First in Human (FIH), Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy|
|Actual Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||February 2022|
The dose escalation phase includes 10 dose levels of LVGN6051, and the highest dose is up to 10mg/kg. 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).
- Safety/Tolerability [ Time Frame: up to 24 months ]mEvaluate the safety and tolerability and determine the Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and recommended Phase 2 dose(s) (RP2D) of LVGN6051 administered as a single agent (monotherapy) and in combination with pembrolizumab, in adult patients with advanced malignancy.
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): NCT04130542
|Contact: Lynn Jiang, PhDfirstname.lastname@example.org|
|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|