Clinical Trial

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Recruiting Phase 1
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Summary
HF158K1 is an investigational liposome form of doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, encapsulated by lipid membranes containing TL01, a HER2-directed Trastuzumab Fab fragment conjugated lipid.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-05-06; most recent amendment 2026-06-25.
Status change: Not Yet Recruiting → Recruiting 2023-11-10
Trial Details
NCT Number NCT05861895
Lead Sponsor HighField Biopharmaceuticals Corporation
Conditions Solid Tumors, Adult
Enrollment 84 participants
Start Date 2023-12-12
Primary Completion 2027-06-23 (estimated)
Study Completion 2027-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-06-26