Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Solid Tumors, Adult, sponsored by HighField Biopharmaceuticals Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
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 |
What NCT05861895 shows while recruiting
NCT05861895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 243-participant average among 5 other Solid Tumors, Adult trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Solid Tumors, Adult
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
RECRUITING · Phase 1
-
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
RECRUITING · Phase 1
-
Imaging of Solid Tumors Using FAP-2286
RECRUITING · Phase 1
-
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
RECRUITING · Phase 1
-
First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02391519 · 84 participants
Effects of High Altitude on AMPK Activation
- NCT03838536 · 84 participants · NA
Synergistic Activity of Human Milk Nutrients and Infant Cognition
- NCT03884075 · 84 participants · Phase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
- NCT03894917 · 84 participants
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI