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Clinical Trials in the USA / NCT05892718
Recruiting Phase 1

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

NCT05892718 · tracked via the Priya Life Science USA tracker
Sponsor
FBD Biologics Limited
Phase
Phase 1
Started
2023-10-02
Last updated
2026-02-04

Condition(s) studied

Advanced Solid TumorRefractory Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

HCB101

HCB101: HCB101 administered via. intravenous (IV) infusion.

Study summary

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)

Trial sites (8)

FacilityCityRegionStatus
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.

View NCT05892718 on ClinicalTrials.gov ↗ ← All trials in the USA