NCT05861895 HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
| NCT ID | NCT05861895 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | HighField Biopharmaceuticals Corporation |
| Condition | Solid Tumors, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2027-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 84 participants in total. It began in 2023-12-12 with a primary completion date of 2027-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary to participate and sign ICF. 2. Age ≥ 18 and ≤ 75 years. 3. Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+). 4. ECOG score 0-1. 5. Expected survival ≥ 6 months. 6. At least one measurable lesion per RECIST v1.1. 7. Adequate organ function: ANC ≥ 1.5×10⁹/L, LYM ≥ 1.0×10⁹/L, PLT ≥ 90×10⁹/L, HGB ≥ 8.0 g/dL; APTT ≤ 1.5×ULN, INR ≤ 1.5; TBIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN (≤ 5×ULN if liver metastases); CrCl ≥ 30 mL/min; LVEF ≥ 50%. 8. Agreement to use effective contraception. Exclusion Criteria: 1. Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity. 2. Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone). 3. Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C). 4. Symptomatic CNS metastases. 5. Unresolved AEs from prior therapy \> Grade 1. 6. Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension). 7. Active infection or unexplained fever \> 38.5°C. 8. HIV, active HBV or HCV. 9. Pregnant or breastfeeding.
Contact & Investigator
MINAL BARVE
PRINCIPAL INVESTIGATOR
Mary Crowley Cancer Research
Frequently Asked Questions
Who can join the NCT05861895 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumors, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05861895 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05861895 currently recruiting?
Yes, NCT05861895 is actively recruiting participants. Visit ClinicalTrials.gov or contact HighField Biopharmaceuticals Corporation to inquire about joining.
Where is the NCT05861895 trial being conducted?
This trial is being conducted at Dallas, United States, Guangzhou, China.
Who is sponsoring the NCT05861895 clinical trial?
NCT05861895 is sponsored by HighField Biopharmaceuticals Corporation. The principal investigator is MINAL BARVE at Mary Crowley Cancer Research. The trial plans to enroll 84 participants.