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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Able to understand and willing to sign the ICF.
2. Male and female subjects of ≥18 years of age.
3. Histologically/cytologically confirmed, locally advanced solid tumor: subjects with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of therapy.
4. For subjects with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
5. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
6. Must have ECOG performance status of 0 to 2 at Screening.
7. Able to provide tumor tissue samples.
8. Have life expectancy of ≥12 weeks.
Exclusion Criteria:
1. With known history of hypersensitivity to any components of HCB101.
2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
3. Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or have used a radioactive drug that is not completed at least 2 weeks prior to the first dose of HCB101.
4. Clinically significant cardiovascular condition.
5. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia.
6. With known inherited or acquired bleeding disorder or bleeding diathesis. .
7. Have RBC transfusion within 4 weeks prior to Screening.
8. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
9. Any investigational or approved systemic cancer therapy.
10. Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on case by case basis. There will be no restriction for daily aspirin ≤ 81 mg/QD.
11. Have used herbal medication within 14 days prior to the first dose of HCB101.
12. Have received any treatment targeting the CD47 or SIRPα pathway.
13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101.
14. Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB101.
15. An investigational device used within 28 days prior to the first dose of HCB101.
16. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
17. Known to have a history of alcoholism or drug abuse.
Primary outcome measure(s)
Number/incidence and percentage of subjects with adverse events, including ADA. — 12 months To evaluate the safety and tolerability of HCB101
Number of subjects with MTD of HCB101 — 12 months To evaluate the safety and tolerability of HCB101
Trial sites (8)
Facility
City
Region
Status
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie
Florida
Recruiting
Carolina BioOncology
Huntersville
North Carolina
Recruiting
Greenville Hospital System University Medical Center (ITOR)
Greenville
South Carolina
Recruiting
UT Southwestern Medical Center
Dallas
Texas
Recruiting
Hangzhou First People's Hospital
Hangzhou
Zhejiang
Recruiting
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City
Taiwan
Recruiting
National Taiwan University Hospital
Taipei
Taiwan
Recruiting
Taipei Veterans General Hospital
Taipei
Taiwan
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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