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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
NCT05861895 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG HF158K1 /Arm 2 mg/m²
- DRUG HF158K1 /Arm 6 mg/m²
- DRUG HF158K1 /Arm 15 mg/m²
- DRUG HF158K1 /Arm 30 mg/m²
- DRUG HF158K1 /Arm 45 mg/m²
Study Locations (1)
Texas
- Mary Crowley Cancer Research — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2023-12-12 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05861895
The ClinicalTrials.gov registry entry for NCT05861895 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HighField Biopharmaceuticals Corporation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumors, Adult appearing as the primary indexed condition, and to 5 interventions — of which HF158K1 /Arm 2 mg/m² is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05861895 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05861895 about?
NCT05861895 is a clinical study titled "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". 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.
What is the current status of trial NCT05861895?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2023-12-12. Estimated completion is 2025-12-22.
What conditions does trial NCT05861895 study?
This clinical trial studies the following conditions: Solid Tumors, Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05861895?
The interventions under investigation include: HF158K1 /Arm 2 mg/m² (DRUG), HF158K1 /Arm 6 mg/m² (DRUG), HF158K1 /Arm 15 mg/m² (DRUG), HF158K1 /Arm 30 mg/m² (DRUG), HF158K1 /Arm 45 mg/m² (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05861895?
This trial is sponsored by HighField Biopharmaceuticals Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05861895 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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