HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumors, Adult

In brief

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.

Key facts

Study ID

NCT05861895

Run by

HighField Biopharmaceuticals Corporation

People needed

84

Starts

2023-12-12

Expected to finish

2027-12-23

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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