NCT06649708

HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies

A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hanx Biopharmaceuticals (Wuhan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	HX044	Conventional dose-escalation design with 3+3 cohort size. All administered on a Q3 weekly basis. Dose escalation will be based on the absence of DLTs during the 21-day DLT evaluation after a review of safety data by the Safety Review Escalation Committee. Subjects will continue on study treatment until the subject develops an intolerable toxicity, withdraws consent, develops progression of disease, death, lost to follow-up, start of new anticancer treatment or up to study treatment duration of 24 months, whichever comes first.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-10-31
• Completion: 2027-10-31
• First posted: 2024-10-21
• Last updated: 2025-01-14

Locations

3 sites across 1 country: Australia