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

A Phase 1 Clinical Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of HF158K1 in Participants With HER-2 Expressing Advanced Solid Tumors

This study is testing a new treatment called HF158K1 for people with advanced solid tumors that have HER-2 expression to see if it can work better than the treatments they’ve already tried.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: HighField Biopharmaceuticals Corporation (industry)
• Drugs / interventions: doxorubicin, prednisone, Trastuzumab, chemotherapy
• Locations: 2 sites (Dallas, Texas and 1 other locations)
• Trial ID: NCT05861895 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable or metastatic advanced solid tumors that are HER-2 positive or low expression and have failed or are intolerant to standard treatments.

Not a fit: Patients with tumors that do not express HER-2 or those who have not yet received standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new targeted therapy for patients with advanced solid tumors that express HER-2.

How similar studies have performed: Other studies have shown promise with similar HER-2 targeted therapies, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Dallas, Texas and 1 other locations

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

Study contacts

• Principal investigator: MINAL BARVE — Mary Crowley Cancer Research

Conditions: Solid Tumors, Adult