Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT05861895

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Led by HighField Biopharmaceuticals Corporation · Updated on 2026-04-07

84

Participants Needed

2

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Age between 18 and 75 years
  • Have unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+)
  • Have an ECOG performance status score of 0 or 1
  • Expected survival of at least 6 months
  • Have at least one measurable lesion according to RECIST v1.1
  • Have adequate organ function including: ANC ≥ 1.5×10⁹/L, lymphocytes ≥ 1.0×10⁹/L, platelets ≥ 90×10⁹/L, hemoglobin ≥ 8.0 g/dL; APTT ≤ 1.5× upper limit of normal, INR ≤ 1.5; total bilirubin ≤ 1.5× upper limit of normal, ALT/AST ≤ 2.5× upper limit of normal (≤ 5× if liver metastases); creatinine clearance ≥ 30 mL/min; left ventricular ejection fraction ≥ 50%
  • Agree to use effective contraception
Not Eligible

You will not qualify if you...

  • Have received a cumulative doxorubicin dose ≥ 350 mg/m² or have anthracycline-related heart damage
  • Currently using immunosuppressive drugs or systemic corticosteroids over 10 mg/day prednisone
  • Have had anti-tumor therapy within the last 2 weeks (4 weeks for nitrosourea or mitomycin C)
  • Have symptoms from central nervous system metastases
  • Have unresolved adverse events from previous therapy above Grade 1
  • Have serious heart conditions such as thromboembolic events within last 3 months, NYHA class III-IV heart failure, acute coronary syndrome within 6 months, or uncontrolled high blood pressure
  • Have an active infection or unexplained fever above 38.5°C
  • Have HIV infection or active hepatitis B or C infection
  • Are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Mary Crowley Cancer Research

Dallas, Texas, United States, 75241

Actively Recruiting

2

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors | DecenTrialz