Clinical Trial

First in Human, Dose Escalation Study of AN4005

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-08-02; most recent amendment 2025-11-17.
Status change: Not Yet Recruiting → Recruiting 2021-10-13
Trial Details
NCT Number NCT04999384
Lead Sponsor Adlai Nortye Biopharma Co., Ltd.
Conditions Advanced Solid Tumor, Advanced Lymphoma
Enrollment 31 participants
Start Date 2021-09-27
Primary Completion 2026-11 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-18