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
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.
Arms & interventions
- DrugHCB101
HCB101 administered via. intravenous (IV) infusion.
Outcome measures
Primary
Number/incidence and percentage of subjects with adverse events, including ADA.
To evaluate the safety and tolerability of HCB101
Time frame: 12 months
Number of subjects with MTD of HCB101
To evaluate the safety and tolerability of HCB101
Time frame: 12 months
Secondary
Overall Rate Response (ORR)
Time frame: 12 months
Duration of Response (DoR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Peak Plasma Concentration (Cmax) of HCB101
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC) of HCB101
Time frame: 12 months
Time to maximum drug concentration in plasma (Tmax) of HCB101
Time frame: 12 months
Terminal elimination half-life (t1/2) of HCB101
Time frame: 12 months
Eligibility criteria
Study locations (4)
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Carolina BioOncology
Huntersville, North Carolina, 28078
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, 29605
UT Southwestern Medical Center
Dallas, Texas, 75390