Clinical Trial

HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated January 14, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044. HX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-17; most recent amendment 2025-01-13.
Status change: Not Yet Recruiting → Recruiting 2024-11-20
Trial Details
NCT Number NCT06649708
Lead Sponsor Hanx Biopharmaceuticals (Wuhan) Co., Ltd.
Conditions Advanced Solid Tumor Malignancies
Enrollment 100 participants
Start Date 2024-12-30
Primary Completion 2025-10-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-14