First in Human, Dose Escalation Study of AN4005

ClinicalTrials.gov ID: NCT04999384

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ClinicalTrials.gov public records Last synced Nov 12, 2026, 2:25 PM EST

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Official title

Clinical Study Protocol AN4005X0101 An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients With Advanced Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04999384
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Adlai Nortye Biopharma Co., Ltd.; Industry
Enrollment: 31 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 27, 2021 (Actual)
Primary completion: Nov 2026 (Estimated)
Completion: Dec 2026 (Estimated)
Last update posted: Nov 18, 2025

2021 – 2026

United States locations

U.S. sites: 4
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Montefiore Einstein Cancer Center	The Bronx	New York	10461	Recruiting
Prisma Health Institute for Translational Oncology Research	Greenville	South Carolina	29605	Recruiting
Next Virginia	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04999384, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 18, 2025 · Synced Nov 12, 2026