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NCT05861895
HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
Phase 1 trial testing HF158K1 / 1.4 g lipid dose in Solid Tumors, Adult in 84 participants. Currently enrolling.
23 June 2027
Quick facts
| Lead sponsor | HighField Biopharmaceuticals Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 12 December 2023 |
| Primary completion | 23 June 2027 |
| Estimated completion | 23 December 2027 |
| Sites | 2 locations across China, United States |
Drugs / interventions tested
- HF158K1 / 1.4 g lipid dose
- HF158K1 / 2.2 g lipid dose
- HF158K1 / 2.9 g lipid dose
Conditions studied
- Solid Tumors, Adult — all drugs for Solid Tumors, Adult →
Sponsor
HighField Biopharmaceuticals Corporation — full company profile →
Who can join
Adults 18 to 75, any sex, with Solid Tumors, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
HER2-low gastric cancer: is the subgroup targetable?
Shimozaki K, Fukuoka S, Ooki A, Yamaguchi K. · · 2024 · cited 16× · PMID 39178538 · DOI 10.1016/j.esmoop.2024.103679 -
Tissue-agnostic biomarkers in solid tumors: current approvals and emerging candidates.
Kim J, Kim HS, Nam M, Chae YK. · · 2025 · cited 3× · PMID 40576713 · DOI 10.1007/s10555-025-10274-2
Verify or expand the search:
- PubMed search for NCT05861895
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumors, Adult
Currently open trials in the same condition.
- NCT07396584 — HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor · Phase 1, PHASE2 · recruiting
- NCT07417189 — A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) · Phase 1, PHASE2 · recruiting
- NCT07228247 — A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06504368 — Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06404528 — Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours · NA · recruiting
Other HighField Biopharmaceuticals Corporation trials
Trials by the same sponsor.
- NCT06822998 — HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT05386823 — Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05861895 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HighField Biopharmaceuticals Corporation
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05861895.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing