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NCT04999384 · ClinicalTrials.gov registry record · Phase 1
First in Human, Dose Escalation Study of AN4005
A Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma, sponsored by Adlai Nortye Biopharma Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 7
- Study locations
NCT04999384: Recruiting Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma, sponsored by Adlai Nortye Biopharma Co..
NCT04999384 is a Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma that is actively recruiting participants, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 31 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04999384, a Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma, is actively recruiting participants, sponsored by Adlai Nortye Biopharma Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 7
- Study locations
Study Summary
Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 + 3 design" will be utilized for dose finding with dose escalation and/or de-escalation as appropriate.
Primary Outcome
All AEs, SAEs and dose modifications will be collected
Conditions Studied
Interventions
- DRUG AN4005-dose level 0
- DRUG AN4005-dose level 1
- DRUG AN4005-dose level 2
- DRUG AN4005-dose level 3
- DRUG AN4005-dose level 4
Study Locations (7)
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Montefiore Einstein Cancer Center - The Bronx
South Carolina
- Prisma Health Institute for Translational Oncology Research - Greenville
Virginia
- Next Virginia - Fairfax
Beijing Municipality
- Beijing Cancer Hospital - Beijing
Heilongjiang
- Harbin Medical University Cancer Hospital - Harbin
Hubei
- Union Hospital Tongji Medical College Huazhong University of Science and Technology - Wuhan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04999384 shows while recruiting
NCT04999384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which AN4005-dose level 0 is the first listed.
NCT04999384 lists 7 locations in 7 states (New Jersey, New York, South Carolina).
Frequently Asked Questions
What is clinical trial NCT04999384 about?
NCT04999384 is a clinical study titled "First in Human, Dose Escalation Study of AN4005". Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 +...
What is the current status of trial NCT04999384?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-09-27. Estimated completion is 2026-12.
What conditions does trial NCT04999384 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Advanced Lymphoma.
What interventions are being tested in trial NCT04999384?
The interventions under investigation include: AN4005-dose level 0 (DRUG), AN4005-dose level 1 (DRUG), AN4005-dose level 2 (DRUG), AN4005-dose level 3 (DRUG), AN4005-dose level 4 (DRUG).
Who is sponsoring clinical trial NCT04999384?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04999384 being conducted?
This trial has 7 study locations across New Jersey, New York, South Carolina, Virginia, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04999384's enrollment target sits among peer trials
31 175th of 189 higher than 15 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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