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First in Human, Dose Escalation Study of AN4005
NCT04999384 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04999384
The ClinicalTrials.gov registry entry for NCT04999384 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adlai Nortye Biopharma Co., which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04999384 reports 7 study locations spanning 7 distinct geographic areas — top geographies include New Jersey, New York, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04999384?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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