NCT04999384

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Adlai Nortye Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, one sentinel patient will be dosed at 50 mg first, then increasing doses of AN4005 will be administered to cohorts of 3 subjects, at doses ranging from 100 mg twice daily (BID) to 600 mg BID (see the table below). The proposed starting dose, 50 mg BID, has been selected based on integrated data from nonclinical studies. If 50 mg BID for one cycle is deemed to be tolerable upon review of safety data, the dose of AN4005 will be escalated to 100 mg BID in a cohort of 3 patients, and further dose escalations will be performed in separate cohorts based on review of data from all preceding cohorts. The dose escalation will be conducted in a sequential manner. Intermediate dose levels (decrement) may be explored. Decisions with regard to dose escalation to next dose level will be made jointly by the investigators and the sponsor. AE data collected for approximately 90 days following the end of exposure will also be used to inform the final dose and schedule. A minimum of 6 patients will be treated at the MTD/RP2D.

Conditions

• Advanced Solid Tumor
• Advanced Lymphoma

Interventions

Type	Name	Description
DRUG	AN4005-dose level 0	50mg BID
DRUG	AN4005-dose level 1	100mg BID
DRUG	AN4005-dose level 2	200mg BID
DRUG	AN4005-dose level 3	400mg BID
DRUG	AN4005-dose level 4	600mg BID
DRUG	AN4005-food effect	Dose to be determined upon the MTD determination

Timeline

• Start date: 2021-09-27
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2021-08-10
• Last updated: 2025-11-18

Locations

7 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study