The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
This is a phase 1, open-label, multicenter, dose-escalation study. This study is to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and identification of maximum tolerated dose (MTD) of HCB301 intravenous injection in adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
HCB301 administered via. intravenous (IV) infusion.
Prisma Health-Upstate
Greenville, South Carolina, United States
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
RECRUITINGZhejiang Provincial Cancer Hospital
Hangzhou, China
Number/incidence and percentage of subjects with adverse events, including ADA.
To evaluate the safety and tolerability of HCB301.
Time frame: 12 months
Number of subjects with MTD and RDE of HCB301.
To determine the MTD and RDE.
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 HCB301
Peak Plasma Concentration (Cmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels.
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC) of HCB301
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Xuzhou Central Hospital
Xuzhou, China
RECRUITINGYantai Yuhuangding Hospital
Yantai, China
RECRUITINGSouthern Medical University Zhujiang Hospital
Zhujiang, China
RECRUITINGArea under the plasma concentration versus time curve (AUC) of HCB301 following single and repeated IV doses of HCB301 at different dose levels.
Time frame: 12 months
Time to maximum drug concentration in plasma (Tmax) of HCB301
Time to maximum drug concentration in plasma (Tmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels.
Time frame: 12 months
Terminal elimination half-life (t1/2) of HCB301
Terminal elimination half-life (t1/2) of HCB301 following single and repeated IV doses of HCB301 at different dose levels.
Time frame: 12 months