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Brief Title: A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
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
Study ID: NCT05892718
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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