HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

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 Criteria:

1. Voluntary to participate and sign ICF.
2. Age ≥ 18 and ≤ 75 years.
3. Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).
4. ECOG score 0-1.
5. Expected survival ≥ 6 months.
6. At least one measurable lesion per RECIST v1.1.
7. 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%.
8. Agreement to use effective contraception.

Exclusion Criteria:

1. Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity.
2. Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone).
3. Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C).
4. Symptomatic CNS metastases.
5. Unresolved AEs from prior therapy \> Grade 1.
6. Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension).
7. Active infection or unexplained fever \> 38.5°C.
8. HIV, active HBV or HCV.
9. Pregnant or breastfeeding.

Conditions2

Interventions9

Locations1 site

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