RecruitingPhase 1NCT05892718

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

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


Sponsor

FBD Biologics Limited

Enrollment

80 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase safety study tests HCB101, a new drug designed to help the immune system recognize and attack cancer cells by blocking a "do not eat me" signal (the CD47-SIRPα pathway), in people with advanced solid tumors or blood cancers. **You may be eligible if...** - You are 18 or older - You have a solid tumor or blood cancer confirmed by biopsy that has stopped responding to standard treatments - You are willing to provide tissue for analysis **You may NOT be eligible if...** - Your cancer still has available standard treatment options - You are unable to give informed consent - You have conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHCB101

HCB101 administered via. intravenous (IV) infusion.


Locations(8)

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

View Full Details on ClinicalTrials.gov

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NCT05892718


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