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Clinical Trials in the USA / NCT05861895
Recruiting Phase 1

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

NCT05861895 · tracked via the Priya Life Science USA tracker
Sponsor
HighField Biopharmaceuticals Corporation
Phase
Phase 1
Started
2023-12-12
Last updated
2026-06-26

Condition(s) studied

Solid Tumors, Adult

Investigational drug(s) / intervention(s)

HF158K1 / 1.4 g lipid doseHF158K1 / 2.2 g lipid doseHF158K1 / 2.9 g lipid dose

HF158K1 / 1.4 g lipid dose: 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.

HF158K1 / 2.2 g lipid dose: 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.

HF158K1 / 2.9 g lipid dose: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Mary Crowley Cancer Research Dallas Texas Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

Other trials for the same condition

Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors Active, not recruiting
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors Recruiting
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors Recruiting
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors Recruiting
HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05861895 on ClinicalTrials.gov ↗ ← All trials in the USA