NCT05861895 · HighField Biopharmaceuticals Corporation
HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
What this study is about
HF158K1 is an experimental liposome form of doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, encapsulated by lipid membranes containing TL01, a HER2-directed Trastuzumab Fab fragment conjugated lipid.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
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.
DRUG
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.
Primary outcome measures
Incidence of Adverse Events
Time frame: The period of AE collection starts after the participant receives the investigational drug, until 28±3 days after the EOT/early withdrawal or before the participant starts another anti-tumor treatment (whichever occurs first).
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Incidence of dose-limiting toxicities(DLT)
Time frame: The DLT evaluation period is from the first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.（only Ia）
Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed
Red blood cell count in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Red blood cell count in whole blood
White blood cell in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for white blood cell count in whole blood
Hematocrit in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Hematocrit in whole blood
Neutrophil count in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for neutrophil count in whole blood
Hemoglobin concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for hemoglobin concentration in whole blood
Percentage of lymphocytes (LYM%)
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Percentage of lymphocytes (LYM%) in whole blood
Lymphocyte count
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Lymphocyte count in whole blood
Percentage of neutrophils (NEU%) Percentage of neutrophils (NEU%)
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Percentage of neutrophils (NEU%) in whole blood
Platelet count in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Platelet count in whole blood
Prothrombin time in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Prothrombin time in whole blood sample
International normalized ratio in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for international standardized ratio in whole blood sample
Fibrinogen in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Fibrinogen in whole blood
Activated partial prothrombin time in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for activated partial thromboplastin time in whole blood sample
Total bilirubin concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for total bilirubin concentration in whole blood sample
ALT concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for alanine aminotransferase(ALT) concentration in whole blood sample
AST concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for aspartate aminotransferase(AST) concentration in whole blood sample
Total protein concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for total protein concentration in whole blood sample
Urea concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for urea concentration in whole blood sample
Creatinine concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for creatinine concentration in whole blood sample
Total cholesterol concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for total cholesterol concentration in whole blood sample
Triglycerides concentration in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for triglycerides concentration in whole blood sample
HDL-C in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for high density lipoprotein cholesterol (HDL-C) in whole blood sample
LDL-C in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for low density lipoprotein cholesterol (LDL-C) in whole blood sample
Glucose in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Lactic dehydrogenase in whole blood
Alkaline phosphatase in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Lactic dehydrogenase in whole blood
Lactic dehydrogenase in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Lactic dehydrogenase in whole blood
Gamma-glutamyl transferase in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Gamma-glutamyl transferase in whole blood
Albumin in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Albumin in whole blood
Direct bilirubin in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Direct bilirubin in whole blood
Sodium in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Sodium in whole blood
Potassium in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Potassium in whole blood
Chloride in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Chloride in whole blood
Calcium in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Calcium in whole blood
Phosphate in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Phosphate in whole blood
Uric acid in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Uric acid in whole blood
Creatine kinase in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Creatine kinase in whole blood
Creatine kinase isoenzyme in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Creatine kinase isoenzyme in whole blood
Troponin-T (TnT) in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Troponin-T in whole blood
Troponin-I (TnI) in whole blood sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Troponin-I in whole blood
Urine protein in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Urine protein in urine sample
Red blood cells in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Red blood cells in urine sample
White blood cells in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for White blood cells in urine sample
PH in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for pH in urine sample
Ketone bodies in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Ketone bodies in urine sample
Urine glucose in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Urine glucose in urine sample
Urine bilirubin in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Urine bilirubin in urine sample
Urine occult blood in urine sample
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Urine occult blood in urine sample
Heart Rate in beats per minute in beats per minute of ECG
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for heart rate in beats per minute
RR Interval by ECG
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for RR interval by ECG
PR Interval by ECG
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for PR interval by ECG
QRS Interval by ECG
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for QRS interval by ECG
QT Interval by ECG
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for QT interval by ECG
QTcF by ECG
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for QTcF interval by ECG
Left ventricular ejection fraction measured by Echocardiography
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Left ventricular ejection fraction measured by Echocardiography
Body (Ear) Temperature measurement in Vital Signs
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Body (Ear) Temperature
Pulse measurement in Vital Signs
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Pulse
Respiration Rate measurement in Vital Signs
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for respiration rate in breaths of Vital Signs
Sitting Systolic Blood Pressure
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Sitting Systolic Blood Pressure
Sitting Diastolic Blood Pressure
Time frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Changes from baseline for Sitting Diastolic Blood Pressure
The recommended Phase II dose
Time frame: After the end of the dose Expansion Phase（only Ic）
Determine the Recommended Phase II Dose(mg/㎡) of HF158K1 and provide references for dose selection in future clinical studies.
Determine the maximum tolerated dose
Time frame: The first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.
The dose at which the incidence of DLT was closest to the target probability of toxicity (30%).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations