A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
Start Date
10/2/2023
Completion Date
11/15/2029
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.
Detailed Description
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
Age Range: 18 years to No maximum
Interventions
HCB101
Conditions
Locations
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida 34952
United States
Carolina BioOncology
Huntersville, North Carolina 28078
United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina 29605
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Hangzhou First People's Hospital
Hangzhou, Zhejiang 310000
China
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan