Recruiting

Phase 1

HF158K1HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Sponsor:

HighField Biopharmaceuticals Corporation

Code:

NCT05861895

Conditions

Solid Tumors, Adult

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

HF158K1 / 1.4 g lipid dose

HF158K1 / 2.2 g lipid dose

HF158K1 / 2.9 g lipid dose

Study Details

Brief 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.

Conditions

Solid Tumors, Adult

Study ID

NCT05861895

Start date

Dec 12, 2023

Status verified date

Mar, 2026

Completion date

Dec 23, 2027

Anticipated

Primary completion date

Jun 23, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation: HF158K1 1.4 g lipid dose

Participants in this dose group (1.4 g lipid dose) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.

experimental: Dose escalation: HF158K1 2.2 g lipid dose

Participants in this dose group (2.2 g lipid dose) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.

experimental: Dose escalation: HF158K1 2.9 g lipid dose

Participants in this dose group (2.9 g lipid dose) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.

Interventions

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

HF158K1 / 2.9 g lipid dose

Primary outcome measure

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). ]
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） ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
Lymphocyte count [ Time Frame: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
The recommended Phase II dose [ Time Frame: After the end of the dose Expansion Phase（only Ic） ]
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. ]

Central Contacts and Locations

Locations

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75241

Contacts

MINAL BARVE

972-566-3000 MBarve@MaryCrowley.org

More Information

Sponsor

HighField Biopharmaceuticals Corporation

Last update posted

Jun 26, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HighField Biopharmaceuticals Corporation on 2026-06-26.