Clinical Trial

HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors

Study acronym: HF50
Recruiting Early Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated August 17, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-06.
Status change: Not Yet Recruiting → Recruiting 2025-08-12
Trial Details
NCT Number NCT06822998
Lead Sponsor HighField Biopharmaceuticals Corporation
Conditions Advanced Solid Tumors
Enrollment 10 participants
Start Date 2025-06-11
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-17