HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
A Phase 1 Clinical Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of HF158K1 in Participants With HER-2 Expressing Advanced Solid Tumors
HighField Biopharmaceuticals Corporation
84 participants
Dec 12, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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.
- Expected survival ≥ 6 months.
- At least one measurable lesion per RECIST v1.1.
- Adequate organ function: ANC ≥ 1.5×10⁹/L, LYM ≥ 1.0×10⁹/L, PLT ≥ 90×10⁹/L, HGB ≥ 8.0 g/dL; APTT ≤ 1.5×ULN, INR ≤ 1.5; TBIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN (≤ 5×ULN if liver metastases); CrCl ≥ 30 mL/min; LVEF ≥ 50%.
- Agreement to use effective contraception.
Exclusion Criteria9
- 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.
- Unresolved AEs from prior therapy > Grade 1.
- Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension).
- Active infection or unexplained fever > 38.5°C.
- HIV, active HBV or HCV.
- Pregnant or breastfeeding.
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Interventions
Duration of infusion: HF158K1 is diluted using 5% (50 mg/ml) glucose injection or 0.9% sodium chloride injection (saline) to a total volume of 250 ml and is administered through intravenous infusion for 90 ± 10 min.
Duration of infusion: HF158K1 is diluted using 5% (50 mg/ml) glucose injection or 0.9% sodium chloride injection (saline) to a total volume of 250 ml and is administered through intravenous infusion for 90 ± 10 min.
Duration of infusion: HF158K1 is diluted using 5% (50 mg/ml) glucose injection or 0.9% sodium chloride injection (saline) to a total volume of 250 ml and is administered through intravenous infusion for 90 ± 10 min.
Locations(2)
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NCT05861895