Actively Recruiting
A Phase 1, Open-label, Multi-center, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HCB101 in Subjects With Advanced Solid Tumors or Relapsed and Refractory Non-Hodgkin Lymphoma
Led by FBD Biologics Limited · Updated on 2026-02-04
80
Participants Needed
8
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of HCB101, an intravenous Fc-fusion protein targeting the SIRPα-CD47 pathway, in adults aged 18 years and older with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. This Phase 1, open-label, multi-center study aims to identify the maximum tolerated dose and monitor any side effects in participants who have failed standard therapies or are considered unsuitable for such treatments. Participants will receive HCB101 through intravenous injection at gradually increasing doses, starting from 0.08 mg/kg up to 36 mg/kg sequentially. Treatment will continue until unacceptable adverse events, disease progression, withdrawal, loss to follow-up, death, or study termination. The study involves dose escalation to determine the optimal dose level for further research. During the study, participants will undergo regular safety monitoring, blood sampling for pharmacokinetics, and tumor assessments using established criteria. Researchers will measure adverse event rates, immune responses, tumor response rates, and drug concentration over a 12-month period. The study includes comprehensive evaluation of anti-tumor effects and safety, with participants followed until study completion or withdrawal.
CONDITIONS
Brief 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 informed consent.
- Male or female aged 18 years or older.
- Histologically or cytologically confirmed advanced solid tumors refractory to standard therapy or non-Hodgkin lymphoma relapsed or refractory after at least 2 prior treatments.
- At least one measurable lesion by RECIST v1.1 for solid tumors.
- Measurable or assessable non-Hodgkin lymphoma by Lugano Classification.
- ECOG performance status of 0 to 2.
- Able to provide tumor tissue samples.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Known allergy to any components of HCB101.
- Active or untreated brain metastases or carcinomatous meningitis.
- Major surgery, radical or palliative radiotherapy, or radioactive drug treatment within 2 weeks before first dose.
- Significant cardiovascular disease.
- Unresolved treatment-related toxicities above Grade 1, except hair loss and anemia.
- Known bleeding disorders or recent blood transfusion.
- Diagnosis of hemolytic anemia or Evans Syndrome within last 3 months.
- Current or recent systemic cancer therapy.
- Active use of vitamin K antagonist anticoagulants like warfarin.
- Use of herbal medication within 14 days before first dose.
- Prior treatments targeting CD47 or SIRPα pathways.
- Other malignancies requiring treatment within 2 years before first dose.
- Participation in another investigational study within 14 days before first dose.
- Use of investigational devices within 28 days before first dose.
- Positive for hepatitis B or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until unacceptable side effects, disease progression, withdrawal, loss to follow-up, death, or study termination.
Participants receive intravenous infusions of HCB101 at escalating doses to evaluate safety, tolerability, and anti-tumor activity.
Repeated visits for intravenous infusions and assessments throughout treatment duration
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
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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