drugset / Trial / NCT06822998
HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.
Timeline
- Start
- 2025-06-11
- Primary completion
- 2026-03-01
- Completion
- 2026-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HF50 | Other / unclassified | 1 mg | Intravenous |
| Subject | HF50 | Other / unclassified | 10 mg | Intravenous |
| Subject | HF50 | Other / unclassified | 60 mg | Intravenous |
| Subject | HF50 | Other / unclassified | 240 mg | Intravenous |