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New treatment option for Solid Tumors, Adult
Official title HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05861895
What this study is testing
What is HF158K1 / 1.4 g lipid dose?
HF158K1 / 1.4 g lipid dose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumors, adult.
Also referred to as Infusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary to participate and sign ICF.
- Age ≥ 18 and ≤ 75 years.
- Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).
- ECOG score 0-1.
- Expected survival ≥ 6 months.
You likely can't join if
- Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity.
- Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone).
- Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C).
- Symptomatic CNS metastases.
- Unresolved AEs from prior therapy \> Grade 1.
- Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension).
See the full eligibility criteria
- Voluntary to participate and sign ICF.
- Age ≥ 18 and ≤ 75 years.
- Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).
- ECOG score 0-1.
- Expected survival ≥ 6 months.
- At least one measurable lesion per RECIST v1.1.
- 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%.
- Agreement to use effective contraception.
- Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity.
- Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone).
- Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C).
- Symptomatic CNS metastases.
- Unresolved AEs from prior therapy \> Grade 1.
- Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension).
- Active infection or unexplained fever \> 38.5°C.
- HIV, active HBV or HCV.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States; Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.