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NCT05861895 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Solid Tumors, Adult, sponsored by HighField Biopharmaceuticals Corporation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT05861895 is a Phase 1 study of Solid Tumors, Adult that is actively recruiting participants, run by HighField Biopharmaceuticals Corporation. The registered enrollment target is 84 participants, below the 243-participant average among 5 other Solid Tumors, Adult trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05861895, a Phase 1 study of Solid Tumors, Adult, is actively recruiting participants, sponsored by HighField Biopharmaceuticals Corporation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 243-participant average among 5 other Solid Tumors, Adult trials with a reported enrollment target (65% lower). The listed sponsor is HighField Biopharmaceuticals Corporation, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05861895 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
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.
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).
Who is sponsoring clinical trial NCT05861895?
This trial is sponsored by HighField Biopharmaceuticals Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.