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A Multi-Regional, Open-Label, Dose Escalation and Dose Expansion Phase I 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

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Trial Profile

A Multi-Regional, Open-Label, Dose Escalation and Dose Expansion Phase I 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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 24 Apr 2025

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At a glance

  • Drugs HF 158K1 (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Cervical cancer; Colon cancer; Gastric cancer; Lung cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Solid tumours; Uterine cancer
  • Focus Adverse reactions
  • Sponsors HighField Biopharmaceuticals

Most Recent Events

  • 21 Apr 2025 According to a HighField Biopharmaceuticals media release, the company as filed two investigational new drug (IND) applications (HF158K1 and HFK2) with Chinas National Medical Products Administration for immunoliposomes carrying different cancer killing payloads. This study will evaluate the two drugs safety and pharmacokinetics as well as their combined therapeutic effects in solid tumor patients refractory to prior treatments.
  • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 28 May 2024 Results presented in the HighField Biopharmaceuticals media release.

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