RecruitingPhase 1NCT04999384

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


Sponsor

Adlai Nortye Biopharma Co., Ltd.

Enrollment

31 participants

Start Date

Sep 27, 2021

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new cancer drug called AN4005 in people with advanced solid tumors or certain types of lymphoma that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older with advanced cancer (solid tumors or lymphoma) that has spread or cannot be removed by surgery - Standard treatments are no longer working or are not available for you - Your heart function is good (ejection fraction above 50%) - Your blood counts, liver, and kidney function meet minimum thresholds - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - Your cancer has not been confirmed by biopsy - You are pregnant or breastfeeding - Your blood counts, liver, or kidney function are too low - Your general health is too poor to participate (performance status worse than 1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAN4005-dose level 0

50mg BID

DRUGAN4005-dose level 1

100mg BID

DRUGAN4005-dose level 2

200mg BID

DRUGAN4005-dose level 3

400mg BID

DRUGAN4005-dose level 4

600mg BID

DRUGAN4005-food effect

Dose to be determined upon the MTD determination


Locations(7)

Hackensack University Medical Center

Hackensack, New Jersey, United States

Montefiore Einstein Cancer Center

The Bronx, New York, United States

Prisma Health Institute for Translational Oncology Research

Greenville, South Carolina, United States

Next Virginia

Fairfax, Virginia, United States

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

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NCT04999384


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