Actively Recruiting
HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
Led by HighField Biopharmaceuticals Corporation · Updated on 2025-08-17
10
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.
CONDITIONS
Official Title
HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years who can provide written informed consent and comply with study requirements
- Confirmed advanced HER-2 positive or HER-2 low-expression solid tumors that are unresectable, metastatic, relapsed after standard therapies, intolerant to standard therapies, or lack effective options
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- At least one measurable lesion by RECIST version 1.1
- Adequate organ and bone marrow function based on specified laboratory values
- Female participants of childbearing potential must have a negative serum pregnancy test and all participants of childbearing potential must agree to use effective contraception during the study and for 6 months after last dose
You will not qualify if you...
- History of active autoimmune disease unsuitable for study except localized skin conditions or resolved childhood asthma
- Use of immunosuppressants or systemic corticosteroids above 10 mg/day prednisone equivalent within 4 weeks prior to first dose
- Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy less than 2 weeks (or 4 weeks for nitrosourea or mitomycin C) before first dose
- Symptomatic brain metastases or leptomeningeal disease unless treated with no progression for at least 28 days and off systemic steroids for 14 days prior to first dose
- Unresolved toxicities from prior therapies of grade 2 or higher except alopecia or stable hypothyroidism
- Significant cardiovascular or cerebrovascular conditions including recent thromboembolic events, NYHA Class III/IV heart failure, recent acute coronary syndrome or stroke, and uncontrolled hypertension unless controlled
- Active infection or unexplained fever over 38.5°C within 1 week prior to first dose
- Known HIV infection or active hepatitis B or C infection above normal limits
- Gastrointestinal symptoms or other conditions requiring intervention within 4 weeks prior to first dose impairing study participation
- Pregnant or breastfeeding women
- Any other severe systemic disease, psychological condition, or clinical abnormality deemed unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Z
Zelei Dai, MMedSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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