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NCT04999384 · ClinicalTrials.gov registry record · Phase 1

First in Human, Dose Escalation Study of AN4005

A Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma, sponsored by Adlai Nortye Biopharma Co..

Recruiting
Registry status
Phase 1
Development phase
31
Enrollment target
7
Study locations

NCT04999384 is a Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma that is actively recruiting participants, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 31 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT04999384, a Phase 1 study of Advanced Solid Tumor and Advanced Lymphoma, is actively recruiting participants, sponsored by Adlai Nortye Biopharma Co..

RECRUITING
Registry status
Phase 1
Development phase
31 participants
Enrollment target
7
Study locations

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 Studied

Advanced Solid Tumor Advanced Lymphoma

Interventions

  • DRUG AN4005-dose level 0
  • DRUG AN4005-dose level 1
  • DRUG AN4005-dose level 2
  • DRUG AN4005-dose level 3
  • DRUG AN4005-dose level 4

Study Locations (7)

New Jersey

  • Hackensack University Medical Center - Hackensack

New York

  • Montefiore Einstein Cancer Center - The Bronx

South Carolina

  • Prisma Health Institute for Translational Oncology Research - Greenville

Virginia

  • Next Virginia - Fairfax

Beijing Municipality

  • Beijing Cancer Hospital - Beijing

Heilongjiang

  • Harbin Medical University Cancer Hospital - Harbin

Hubei

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology - Wuhan

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2021-09-27
Est. Completion 2026-12
Phase Phase 1

Sponsor

Adlai Nortye Biopharma Co.

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04999384

The ClinicalTrials.gov registry entry for NCT04999384 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% lower). The listed sponsor is Adlai Nortye Biopharma Co., which has 6 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which AN4005-dose level 0 is the first listed.

NCT04999384 reports 7 study locations spanning 7 distinct geographic areas - top geographies include New Jersey, New York, South Carolina.

Frequently Asked Questions

What is clinical trial NCT04999384 about?

NCT04999384 is a clinical study titled "First in Human, Dose Escalation Study of AN4005". 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 +...

What is the current status of trial NCT04999384?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-09-27. Estimated completion is 2026-12.

What conditions does trial NCT04999384 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Advanced Lymphoma.

What interventions are being tested in trial NCT04999384?

The interventions under investigation include: AN4005-dose level 0 (DRUG), AN4005-dose level 1 (DRUG), AN4005-dose level 2 (DRUG), AN4005-dose level 3 (DRUG), AN4005-dose level 4 (DRUG).

Who is sponsoring clinical trial NCT04999384?

This trial is sponsored by Adlai Nortye Biopharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04999384 being conducted?

This trial has 7 study locations across New Jersey, New York, South Carolina, Virginia, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.