Solid Tumors, AdultPhase 1NCT05861895
HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
A Phase 1 study testing HF158K1 / 1.4 g lipid dose, HF158K1 / 2.2 g lipid dose and HF158K1 / 2.9 g lipid dose in people with Solid Tumors, Adult, run by HighField Biopharmaceuticals Corporation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- HF158K1 / 1.4 g lipid dose, HF158K1 / 2.2 g lipid dose and HF158K1 / 2.9 g lipid dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Dec 2023to 23 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- Active infection or unexplained fever > 38.5°C.
- HIV, active HBV or HCV.
- Pregnant or breastfeeding.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75241
MINAL BARVE, 972-566-3000, MBarve@MaryCrowley.org
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Kai Yao, PhD, yaokai@sysucc.org.cn
Kai Yao
About this study
Official title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of HF158K1 in Participants With HER-2 Expressing Advanced Solid Tumors
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.
Read the detailed description
This study is a multi-regional, open-label, multiple-dose administration dose-escalation and dose-expansion study, including a Dose-Escalation Phase (Ia) and a Dose-Expansion Phase (Ib).
HF158K1 contains multiple copies of the targeting antibody on liposome surface. It is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels. The study recruits patients with unresectable or metastatic advanced solid tumors (HER-2 positive (IHC 3+, or IHC 2+ with ISH +) or HER-2 low expression (IHC 2+ with ISH -, or IHC 1+)) who have failed or are intolerant (disease progression, or intolerance to chemotherapy, targeted therapy, etc.) to standard treatment, or currently have no available treatment regimen.
Phase 1a(Dose escalation) will assess the safety，tolerability，pharmacokinetics of HF158K1 in participants to determine the maximum tolerated dose (MTD) of HF158K1 through the incidence of dose-limiting toxicity (DLT).
Phase 1b (Dose bridging) will be conducted in Chinese patients to bridge the safety and pharmacokinetic data between different ethnic populations.
Phase 1c(Dose expansion) will assess safety and preliminary efficacy of HF158K1 in participants with specific tumor types in selected dose groups.
- Conditions
- Solid Tumors, Adult
- Being tested
- HF158K1 / 1.4 g lipid dose, HF158K1 / 2.2 g lipid dose, HF158K1 / 2.9 g lipid dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF158K1 / 1.4 g lipid doseDrug
Also called Infusion
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 doseDrug
Also called Infusion
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 doseDrug
Also called Infusion
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 group | Role | What they receive |
|---|---|---|
| Dose escalation: HF158K1 1.4 g lipid dose | Experimental | 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. Receives: Drug: HF158K1 / 1.4 g lipid dose |
| Dose escalation: HF158K1 2.2 g lipid dose | Experimental | 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. Receives: Drug: HF158K1 / 2.2 g lipid dose |
| Dose escalation: HF158K1 2.9 g lipid dose | Experimental | 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. Receives: Drug: HF158K1 / 2.9 g lipid dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Measured: 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)
Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed
Measured: 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
Changes from baseline for Red blood cell count in whole blood
Measured: 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
Changes from baseline for white blood cell count in whole blood
Measured: 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
Changes from baseline for Hematocrit in whole blood
Measured: 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
Changes from baseline for neutrophil count in whole blood
Measured: 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
Changes from baseline for hemoglobin concentration in whole blood
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Percentage of lymphocytes (LYM%)
Changes from baseline for Percentage of lymphocytes (LYM%) in whole blood
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Lymphocyte count
Changes from baseline for Lymphocyte count in whole blood
Measured: 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%)
Changes from baseline for Percentage of neutrophils (NEU%) in whole blood
Measured: 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
Changes from baseline for Platelet count in whole blood
Measured: 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
Changes from baseline for Prothrombin time in whole blood sample
Measured: 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
Changes from baseline for international standardized ratio in whole blood sample
Measured: 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
Changes from baseline for Fibrinogen in whole blood
Measured: 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
Changes from baseline for activated partial thromboplastin time in whole blood sample
Measured: 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
Changes from baseline for total bilirubin concentration in whole blood sample
Measured: 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
Changes from baseline for alanine aminotransferase(ALT) concentration in whole blood sample
Measured: 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
Changes from baseline for aspartate aminotransferase(AST) concentration in whole blood sample
Measured: 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
Changes from baseline for total protein concentration in whole blood sample
Measured: 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
Changes from baseline for urea concentration in whole blood sample
Measured: 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
Changes from baseline for creatinine concentration in whole blood sample
Measured: 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
Changes from baseline for total cholesterol concentration in whole blood sample
Measured: 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
Changes from baseline for triglycerides concentration in whole blood sample
Measured: 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
Changes from baseline for high density lipoprotein cholesterol (HDL-C) in whole blood sample
Measured: 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
Changes from baseline for low density lipoprotein cholesterol (LDL-C) in whole blood sample
Measured: 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
Changes from baseline for Lactic dehydrogenase in whole blood
Measured: 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
Changes from baseline for Lactic dehydrogenase in whole blood
Measured: 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
Changes from baseline for Lactic dehydrogenase in whole blood
Measured: 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
Changes from baseline for Gamma-glutamyl transferase in whole blood
Measured: 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
Changes from baseline for Albumin in whole blood
Measured: 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
Changes from baseline for Direct bilirubin in whole blood
Measured: 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
Changes from baseline for Sodium in whole blood
Measured: 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
Changes from baseline for Potassium in whole blood
Measured: 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
Changes from baseline for Chloride in whole blood
Measured: 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
Changes from baseline for Calcium in whole blood
Measured: 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
Changes from baseline for Phosphate in whole blood
Measured: 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
Changes from baseline for Uric acid in whole blood
Measured: 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
Changes from baseline for Creatine kinase in whole blood
Measured: 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
Changes from baseline for Creatine kinase isoenzyme in whole blood
Measured: 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
Changes from baseline for Troponin-T in whole blood
Measured: 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
Changes from baseline for Troponin-I in whole blood
Measured: 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
Changes from baseline for Urine protein in urine sample
Measured: 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
Changes from baseline for Red blood cells in urine sample
Measured: 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
Changes from baseline for White blood cells in urine sample
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
PH in urine sample
Changes from baseline for pH in urine sample
Measured: 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
Changes from baseline for Ketone bodies in urine sample
Measured: 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
Changes from baseline for Urine glucose in urine sample
Measured: 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
Changes from baseline for Urine bilirubin in urine sample
Measured: 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
Changes from baseline for Urine occult blood in urine sample
Measured: 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
Changes from baseline for heart rate in beats per minute
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
RR Interval by ECG
Changes from baseline for RR interval by ECG
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
PR Interval by ECG
Changes from baseline for PR interval by ECG
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
QRS Interval by ECG
Changes from baseline for QRS interval by ECG
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
QT Interval by ECG
Changes from baseline for QT interval by ECG
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
QTcF by ECG
Changes from baseline for QTcF interval by ECG
Measured: 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
Changes from baseline for Left ventricular ejection fraction measured by Echocardiography
Measured: 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
Changes from baseline for Body (Ear) Temperature
Measured: 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
Changes from baseline for Pulse
Measured: 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
Changes from baseline for respiration rate in breaths of Vital Signs
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Sitting Systolic Blood Pressure
Changes from baseline for Sitting Systolic Blood Pressure
Measured: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)
Sitting Diastolic Blood Pressure
Changes from baseline for Sitting Diastolic Blood Pressure
Measured: 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
Determine the Recommended Phase II Dose(mg/㎡) of HF158K1 and provide references for dose selection in future clinical studies.
Measured: After the end of the dose Expansion Phase（only Ic）
Determine the maximum tolerated dose
The dose at which the incidence of DLT was closest to the target probability of toxicity (30%).
Measured: The first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.
Secondary outcomes (11)
HF158K1 pharmacokinetic parameters with Cmax
Maximum plasma concentration (Cmax) after administration of HF158K1
Measured: Within 336 hours after the first and second administration
AUC by plasma concentration of whole blood sample
Area under plasma concentration -time curve after dose
Measured: Within 336 hours after the first and second administration
Tmax by plasma concentration of whole blood sample
Peak time (Tmax) after dose
Measured: Within 336 hours after the first and second administration
T1/2 by plasma concentration of whole blood sample
Elimination half-life (T1/2) after dose
Measured: Within 336 hours after the first and second administration
CL by plasma concentration of whole blood sample
Clearance (CL) after dose
Measured: Within 336 hours after the first and second administration
Vd by plasma concentration of whole blood sample
Volume of distribution(Vd) after dose
Measured: Within 336 hours after the first and second administration
AUClast by plasma concentration of whole blood sample
Ratios of geometric means of AUClast (Area under the plasma concentration-time curve from zero to time of last quantifiable concentration) after dose
Measured: Within 336 hours after the first and second administration
The objective response rate(ORR) of HF158K1
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: ORR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.
disease control rate (DCR) of HF158K1
DCR is defined as the proportion of participants with complete response stable disease and partial response (CR+PR+SD)
Measured: DCR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.
duration of response(DOR) of HF158K1
For duration of response (DOR), the Kaplan-Meier survival curve will be plotted to analyze their maximum, minimum, median and 95% confidence interval descriptively statistically.
Measured: DOR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.
Analysis of immunogenicity
Immunogenicity analyses related to anti-TL01 antibody will be performed based on IMS(Immunogenicity Analysis Set).
Measured: On the first day of the first cycle, on the first day of the fourth cycle, on the 21st day of the eighth cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start12 Dec 2023
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighField Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MINAL BARVE, Principal investigator, Mary Crowley Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861895
- Sponsor's protocol ID
- HF158K1-101
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of HF158K1 in Participants With HER-2 Expressing Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05861895
- Acronym / sponsor ID
- HF158K1-101
- Conditions
- Solid Tumors, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- HighField Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 23 Dec 2027 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multi-regional, open-label, multiple-dose administration dose-escalation and dose-expansion study, including a Dose-Escalation Phase (Ia) and a Dose-Expansion Phase (Ib).
HF158K1 contains multiple copies of the targeting antibody on liposome surface. It is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels. The study recruits patients with unresectable or metastatic advanced solid tumors (HER-2 positive (IHC 3+, or IHC 2+ with ISH +) or HER-2 low expression (IHC 2+ with ISH -, or IHC 1+)) who have failed or are intolerant (disease progression, or intolerance to chemotherapy, targeted therapy, etc.) to standard treatment, or currently have no available treatment regimen.
Phase 1a(Dose escalation) will assess the safety，tolerability，pharmacokinetics of HF158K1 in participants to determine the maximum tolerated dose (MTD) of HF158K1 through the incidence of dose-limiting toxicity (DLT).
Phase 1b (Dose bridging) will be conducted in Chinese patients to bridge the safety and pharmacokinetic data between different ethnic populations.
Phase 1c(Dose expansion) will assess safety and preliminary efficacy of HF158K1 in participants with specific tumor types in selected dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation: HF158K1 1.4 g lipid dose | Experimental | Drug: HF158K1 / 1.4 g lipid doseParticipants 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. |
| Dose escalation: HF158K1 2.2 g lipid dose | Experimental | Drug: HF158K1 / 2.2 g lipid doseParticipants 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. |
| Dose escalation: HF158K1 2.9 g lipid dose | Experimental | Drug: HF158K1 / 2.9 g lipid doseParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF158K1 / 1.4 g lipid doseAlso: InfusionDuration 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 | Dose escalation: HF158K1 1.4 g lipid dose |
| HF158K1 / 2.2 g lipid doseAlso: InfusionDuration 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 | Dose escalation: HF158K1 2.2 g lipid dose |
| HF158K1 / 2.9 g lipid doseAlso: InfusionDuration 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 | Dose escalation: HF158K1 2.9 g lipid dose |
Primary outcome
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%).
11 secondary outcomes
HF158K1 pharmacokinetic parameters with Cmax
Time frame: Within 336 hours after the first and second administration
AUC by plasma concentration of whole blood sample
Time frame: Within 336 hours after the first and second administration
Tmax by plasma concentration of whole blood sample
Time frame: Within 336 hours after the first and second administration
T1/2 by plasma concentration of whole blood sample
Time frame: Within 336 hours after the first and second administration
CL by plasma concentration of whole blood sample
Time frame: Within 336 hours after the first and second administration
Vd by plasma concentration of whole blood sample
Time frame: Within 336 hours after the first and second administration
AUClast by plasma concentration of whole blood sample
Time frame: Within 336 hours after the first and second administration
The objective response rate(ORR) of HF158K1
Time frame: ORR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.
disease control rate (DCR) of HF158K1
Time frame: DCR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.
duration of response(DOR) of HF158K1
Time frame: DOR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.
Analysis of immunogenicity
Time frame: On the first day of the first cycle, on the first day of the fourth cycle, on the 21st day of the eighth cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MINAL BARVE principal investigator
Mary Crowley Cancer Research
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HF158K1 / 1.4 g lipid dose, HF158K1 / 2.2 g lipid dose and HF158K1 / 2.9 g lipid dose in people with Solid Tumors, Adult, run by HighField Biopharmaceuticals Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 63 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.