Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635995
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2020-11-09
Brief Title:
Phase 1 Trial of LVGN7409 CD40 Agonist Antibody as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
Sponsor:
Lyvgen Biopharma Holdings Limited
Organization:
Lyvgen Biopharma Holdings Limited
Study Overview
Official Title:
An Open Label First in Human FIH Phase 1a1b 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
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor the recommended dose for expansion RDE as well as the recommended Phase 2 doses RP2D of LVGN7409 both as a single agent monotherapy and in combination with a fixed dose of anti-PD-1 antibody andor CD137 agonist in the treatment of advanced or metastatic malignancy
This first in human study of LVGN7409 is designed to establish the maximum tolerated dose MTD andor the recommended dose for expansion RDE as well as the recommended Phase 2 doses RP2D of LVGN7409 both as a single agent monotherapy and in combination with a fixed dose of anti-PD-1 antibody andor CD137 agonist in the treatment of advanced or metastatic malignancy
Detailed Description:
This is an open-label non-randomized two-stage FIH Phase 1 study utilizing an accelerated dose escalation followed by a traditional 3 3 dose escalation algorithm to identify the MTD andor RDE and RP2D of LVGN7409 as a single agent monotherapy and in combination with anti-PD-1 antibody andor CD137 agonist The first stage of the study is the dose escalation phase ie Phase 1a The second stage of the study is the dose expansion phase ie Phase 1b During the study dose interruptions andor delays may be implemented based on toxicity Dose modifications are not permitted Intra-patient dose escalations will be allowed for the early dose cohorts single-patient dose groups in Phase 1a Part 1 Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN7409 or anti-PD-1 antibody andor CD137 agonist at the specified cohort dose Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years whichever occurs first However patients who are clinically unstable will discontinue following the initial assessment of disease progression
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