HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHighField Biopharmaceuticals Corporation
About this trial
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.
Eligibility criteria
Qualifiers
Voluntary to participate and sign ICF.
Age ≥ 18 and ≤ 75 years.
Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).
ECOG score 0-1.
Disqualifiers
Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity.
Current use of immunosuppressants or systemic corticosteroids (> 10 mg/day prednisone).
Prior anti-tumor therapy < 2 weeks (4 weeks for nitrosourea/mitomycin C).
Symptomatic CNS metastases.
Trial design
Treatments tested in this trial
- HF158K1 / 1.4 g lipid dose
- HF158K1 / 2.2 g lipid dose
- HF158K1 / 2.9 g lipid dose
Treatment groups
84 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov