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HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies

NCT06649708 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hanx Biopharmaceuticals Pty Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2025-10-31
Completion
2027-10-31

Countries

  • Australia

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 NCT06649708 on ClinicalTrials.gov