First in Human, Dose Escalation Study of AN4005
Clinical Study Protocol AN4005X0101 An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients With Advanced Tumors
Adlai Nortye Biopharma Co., Ltd.
31 participants
Sep 27, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
50mg BID
100mg BID
200mg BID
400mg BID
600mg BID
Dose to be determined upon the MTD determination
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04999384