A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
NCT ID: NCT05892718
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2023-10-02
2029-11-15
Brief Summary
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Detailed Description
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Eligible subjects must have failed standard therapies, been intolerable, or been considered medically inappropriate by the investigator. Subjects will be treated until unacceptable AEs, radiographic or clinical documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study, whichever occurs first.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HCB101
HCB101 in subjects with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
Dosage levels: 0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.64 mg/kg, 1.28 mg/kg, 2.56 mg/kg, and 5.12 mg/kg sequentially.
HCB101
HCB101 administered via. intravenous (IV) infusion.
Interventions
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HCB101
HCB101 administered via. intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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FBD Biologics Limited
INDUSTRY
Responsible Party
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Locations
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Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Carolina BioOncology
Huntersville, North Carolina, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Christine Gerdes
Role: primary
Ashley Wallace
Role: primary
Jill Roemmich
Role: primary
Shannon Garcia
Role: primary
Yu-Yan Hong
Role: primary
Chia-Hsuan Yang
Role: primary
Pei-Ling Chiu
Role: primary
Other Identifiers
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HCB101-101
Identifier Type: -
Identifier Source: org_study_id
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