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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.

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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.

Conditions Studied

Cancer

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

FieldValue
Enrollment Target 276 participants
Start Date 2019-10-31
Est. Completion 2025-12-31
Phase Phase 1

Sponsor

Lyvgen Biopharma Holdings Limited

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04130542

The ClinicalTrials.gov registry entry for NCT04130542 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Lyvgen Biopharma Holdings Limited, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.