NCT05861895View on ClinicalTrials.gov

A Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HF158K1 in Participants With HER-2 Positive or HER-2 Low Expression Advanced Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 12, 2023

Primary Completion Date

April 23, 2025

Study Completion Date

December 22, 2025

Conditions
Solid Tumors, Adult
Interventions
DRUG

HF158K1 /Arm 2 mg/m²

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.

DRUG

HF158K1 /Arm 6 mg/m²

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.

DRUG

HF158K1 /Arm 15 mg/m²

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.

DRUG

HF158K1 /Arm 30 mg/m²

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.

DRUG

HF158K1 /Arm 45 mg/m²

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.

DRUG

HF158K1 /Arm 60 mg/m²

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.

Trial Locations (1)

75241

RECRUITING

Mary Crowley Cancer Research, Dallas

Sponsors
All Listed Sponsors
lead

HighField Biopharmaceuticals Corporation

INDUSTRY