Actively Recruiting
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
Led by FBD Biologics Limited · Updated on 2026-02-04
80
Participants Needed
8
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether IV injection of HCB101 is an effective treatment for different types of advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
CONDITIONS
Official Title
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign the informed consent form
- Male and female subjects aged 18 years or older
- Histologically or cytologically confirmed advanced solid tumors refractory to standard therapy or without standard treatment, or relapsed/refractory non-Hodgkin lymphoma after at least 2 prior therapies
- For advanced solid tumors, at least one measurable lesion per RECIST v1.1 at baseline
- For non-Hodgkin lymphoma, measurable or assessable disease per Lugano Classification (2016 refinement)
- ECOG performance status of 0 to 2 at screening
- Ability to provide tumor tissue samples
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Known hypersensitivity to any component of HCB101
- Active or untreated central nervous system metastases or carcinomatous meningitis
- Major surgery, radical or palliative radiotherapy, or radioactive drug use within 2 weeks before first HCB101 dose
- Clinically significant cardiovascular disease
- Unresolved treatment-related toxicities worse than Grade 1 (except alopecia and anemia)
- Known bleeding disorders or diathesis
- Red blood cell transfusion within 4 weeks before screening
- Diagnosis of hemolytic anemia or Evans Syndrome within last 3 months
- Current investigational or approved systemic cancer therapy
- Active use of vitamin K antagonist anticoagulants like warfarin (exceptions possible for certain anticoagulants and low-dose aspirin)
- Use of herbal medication within 14 days before first HCB101 dose
- Prior treatment targeting CD47 or SIRPα pathway
- Other malignancies requiring treatment within 2 years before first HCB101 dose
- Participation in another clinical study with investigational product within 14 days before first HCB101 dose
- Use of investigational device within 28 days before first HCB101 dose
- Positive for hepatitis B, active hepatitis C, HIV, or active/latent tuberculosis
- History of alcoholism or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Actively Recruiting
2
Carolina BioOncology
Huntersville, North Carolina, United States, 28078
Actively Recruiting
3
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States, 29605
Actively Recruiting
4
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
6
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
Actively Recruiting
7
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
8
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
F
FBD Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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