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NCT04130542 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy
A Phase 1 study of Cancer, sponsored by Lyvgen Biopharma Holdings Limited.
- Active
- Registry status
- Phase 1
- Development phase
- 276
- Enrollment target
- 7
- Study locations
NCT04130542: Active Phase 1 study of Cancer, sponsored by Lyvgen Biopharma Holdings Limited.
NCT04130542 is a Phase 1 study of Cancer that is active but no longer recruiting, run by Lyvgen Biopharma Holdings Limited. The registered enrollment target is 276 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04130542, a Phase 1 study of Cancer, is active but no longer recruiting, sponsored by Lyvgen Biopharma Holdings Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 276 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL LVGN6051
- BIOLOGICAL KEYTRUDA® (pembrolizumab)
Study Locations (7)
California
- University of California Irvine Health - Orange
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Indiana
- Verdi Oncology Research - Lafayette
Maryland
- The Johns Hopkins University - Baltimore
Nebraska
- Nebraska Cancer Specialist - Omaha
New York
- NYU Langone Health - New York
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2019-10-31 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04130542 still lists
NCT04130542 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which LVGN6051 is the first listed.
NCT04130542 lists 7 locations in 6 states (California, Indiana, Maryland).
Frequently Asked Questions
What is clinical trial NCT04130542 about?
NCT04130542 is a clinical study titled "Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy". 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...
What is the current status of trial NCT04130542?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 276 participants. The study started on 2019-10-31. Estimated completion is 2025-12-31.
What conditions does trial NCT04130542 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT04130542?
The interventions under investigation include: LVGN6051 (BIOLOGICAL), KEYTRUDA® (pembrolizumab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04130542?
This trial is sponsored by Lyvgen Biopharma Holdings Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04130542 being conducted?
This trial has 7 study locations across California, Indiana, Maryland, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04130542's enrollment target sits among peer trials
276 194th of 615 higher than 421 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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