TrialPath
← Back to searchRecruiting

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

NCT05892718 · FBD Biologics Limited
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
This is an open-label, multi-center, dose-escalation, Phase 1 study. This study is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and identification of maximum tolerated dose (MTD) of HCB101 intravenous injection in adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. 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.
Eligibility criteria
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.
Study design
Enrollment target: 80 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-02
Estimated completion: 2029-11-15
Last updated: 2026-02-04
Interventions
Drug: HCB101
Primary outcomes
  • Number/incidence and percentage of subjects with adverse events, including ADA. (12 months)
  • Number of subjects with MTD of HCB101 (12 months)
Sponsor
FBD Biologics Limited · industry
Contacts & investigators
ContactFBD Clinical · contact · HCB101-101@hanchorbio.com · +886-2-27921366
All locations (8)
Hematology-Oncology Associates of the Treasure CoastRecruiting
Port Saint Lucie, Florida, United States
Carolina BioOncologyRecruiting
Huntersville, North Carolina, United States
Greenville Hospital System University Medical Center (ITOR)Recruiting
Greenville, South Carolina, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Hangzhou First People's HospitalRecruiting
Hangzhou, Zhejiang, China
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and WelfareRecruiting
New Taipei City, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan