HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHighField Biopharmaceuticals Corporation
About this trial
HF158K1 is an investigational liposome form of doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, encapsulated by lipid membranes containing TL01, a HER2-directed Trastuzumab Fab fragment conjugated lipid.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HF158K1 / 1.4 g lipid dose
DrugDuration 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
DrugDuration of infusion: HF158K1 is diluted using 5% (50 mg/ml) glucose injection or 0.9% sodium chloride injection (saline) to a total volume of 250 ml and is administered through intravenous infusion for 90 ± 10 min.
HF158K1 / 2.9 g lipid dose
DrugDuration 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.
Treatment groups
84 Participants
are divided into 3 treatment groupsGroup A: Dose escalation: HF158K1 1.4 g lipid doseExperimental treatment 1 intervention
Group B: Dose escalation: HF158K1 2.2 g lipid doseExperimental treatment 1 intervention
Group C: Dose escalation: HF158K1 2.9 g lipid doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
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).2
Incidence of dose-limiting toxicities(DLT)
Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed
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）3
Red blood cell count in whole blood sample
Changes from baseline for Red blood cell count in whole blood
Time frame
Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)4
White blood cell in whole blood sample
Changes from baseline for white blood cell count in whole blood
Time frame
Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)Secondary outcomes
1
HF158K1 pharmacokinetic parameters with Cmax
Maximum plasma concentration (Cmax) after administration of HF158K1
Time frame
Within 336 hours after the first and second administration2
AUC by plasma concentration of whole blood sample
Area under plasma concentration -time curve after dose
Time frame
Within 336 hours after the first and second administration3
Tmax by plasma concentration of whole blood sample
Peak time (Tmax) after dose
Time frame
Within 336 hours after the first and second administration4
T1/2 by plasma concentration of whole blood sample
Elimination half-life (T1/2) after dose
Time frame
Within 336 hours after the first and second administrationSponsors and contacts
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Source ClinicalTrials.gov