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First in Human, Dose Escalation Study of AN4005

NCT04999384 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-11-18

No results posted yet for this 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

  • Advanced Solid Tumor
  • Advanced Lymphoma

Interventions

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

Sponsors & Collaborators

  • Adlai Nortye Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kevin Dryer · Adlai Nortye USA Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999384 on ClinicalTrials.gov