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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
HCB101 administered via. intravenous (IV) infusion.
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
RECRUITINGCarolina BioOncology
Huntersville, North Carolina, United States
RECRUITINGNumber/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
Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Time frame: 12 months
Duration of Response (DoR)
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)
Time frame: 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)
Time frame: 12 months
Progression-Free Survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause.
Time frame: 12 months
Peak Plasma Concentration (Cmax) of HCB101
Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC) of HCB101
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Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGHangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGTaipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
RECRUITINGTaipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGArea under the plasma concentration versus time curve (AUC) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months
Time to maximum drug concentration in plasma (Tmax) of HCB101
Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months
Terminal elimination half-life (t1/2) of HCB101
Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months