HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Part of paid clinical trials in Dallas, Texas.

Sponsor
HighField Biopharmaceuticals Corporation
Study ID
NCT05861895
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumors, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HF158K1 / 1.4 g lipid dose — DRUG
    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 — DRUG
    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 dose — DRUG
    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 Details

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.

Key Dates

Start date
Dec 12, 2023
Status verified
Mar 2026
Primary completion
Jun 23, 2027
Completion
Dec 23, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mary Crowley Cancer ResearchDallasTexas75241
MINAL BARVE
[email protected]
972-566-3000

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By research site
Mary Crowley Cancer Research· Dallas, TX

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