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NCT04635995 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
A Phase 1 study of Cancer, sponsored by Lyvgen Biopharma Holdings Limited.
- Active
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT04635995: Active Phase 1 study of Cancer, sponsored by Lyvgen Biopharma Holdings Limited.
NCT04635995 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 126 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04635995, 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
- 126 participants
- Enrollment target
- 1
- Study location
Study 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) 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.
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL LVGN7409
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2020-12-11 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04635995 still lists
NCT04635995 is an interventional study that assigns participants to a tested intervention. The registered 126 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 (96% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which LVGN7409 is the first listed.
NCT04635995 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04635995 about?
NCT04635995 is a clinical study titled "Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy". 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...
What is the current status of trial NCT04635995?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2020-12-11. Estimated completion is 2025-12-31.
What conditions does trial NCT04635995 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT04635995?
The interventions under investigation include: LVGN7409 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04635995?
This trial is sponsored by Lyvgen Biopharma Holdings Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04635995 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04635995's enrollment target sits among peer trials
126 282nd of 615 higher than 331 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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