Investigating a new treatment for advanced solid tumors with HER-2 expression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates HF158K1, a novel liposomal formulation of doxorubicin designed to target HER-2 positive and low expression advanced solid tumors. The study is structured in two phases: a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase to assess safety and preliminary efficacy in specific tumor types. Participants will receive multiple doses of HF158K1 while monitoring safety, tolerability, pharmacokinetics, and immunogenicity. The study aims to provide a targeted treatment option for patients who have exhausted standard therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mary Crowley Cancer Research
  Dallas, Texas, United States Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Minal Barve — Mary Crowley Cancer Research

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.