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HF158K1 for HER-2 Expressing Advanced Solid Tumors

This study is testing a new treatment called HF158K1 for adults (ages 18-75) with advanced solid tumors that express HER-2 (a protein found on some cancer cells). HF158K1 is a special form of a chemotherapy drug designed to target HER-2 positive cancer cells. Researchers want to find out how safe HF158K1 is, what side effects it might cause, and how well it works. You might be able to join if your tumor expresses HER-2 and you have already tried standard treatments or have no other options. The study aims to enroll 84 participants.

Study design
This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It involves different doses of HF158K1 and plans to enroll 84 participants.
What's involved
You would receive HF158K1 through an intravenous (IV) infusion lasting about 90 minutes. You would have blood tests at the start of each 21-day cycle and at the end of treatment.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for about 28 days after your last treatment or early withdrawal, or until you start another anti-tumor treatment. Red blood cell counts will be tracked for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05861895

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Recruiting
PHASE1Ages 18–75InterventionalTreatment
HighField Biopharmaceuticals Corporation
~84 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:HF158K1 / 1.4 g lipid doseHF158K1 / 2.2 g lipid doseHF158K1 / 2.9 g lipid dose

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over 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).
+62 more outcomes measured

Conditions

Solid Tumors, Adult

Explore related trials

Solid NeoplasmERBB2 Gene

Where it's being run

2 sites across 2 states
Texas1
Guangdong1

Study leadership

  • MINAL BARVE · PRINCIPAL_INVESTIGATOR · Mary Crowley Cancer Research

Who to contact

MINAL BARVE
[email protected]
972-566-3000
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Incidence of Adverse EventsThe 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)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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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%)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 countBaseline, 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%)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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 sampleBaseline, 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 ECGBaseline, 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 ECGBaseline, 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 ECGBaseline, 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 ECGBaseline, 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 ECGBaseline, 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 ECGBaseline, 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 EchocardiographyBaseline, 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 SignsBaseline, 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 SignsBaseline, 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 SignsBaseline, 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 PressureBaseline, 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 PressureBaseline, 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 doseAfter 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 doseThe 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%).