RecruitingPhase 1NCT05861895

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

A Phase 1 Clinical Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of HF158K1 in Participants With HER-2 Expressing Advanced Solid Tumors


Sponsor

HighField Biopharmaceuticals Corporation

Enrollment

84 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HF158K1 / 1.4 g lipid dose, a drug called HF158K1 / 2.2 g lipid dose, and others for people with solid tumors, adult. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHF158K1 / 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.

DRUGHF158K1 / 2.2 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.

DRUGHF158K1 / 2.9 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.


Locations(2)

Mary Crowley Cancer Research

Dallas, Texas, United States

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05861895


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