This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1 dose confirmation and Part 2 dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with Toripalimab in patients with advanced HCC and other solid tumors.
subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first. This trial consists of : * A screening period: 28 days * A treatment period: * Part 1 dose confirmation study * Part 2 dose expansion study * A post-treatment follow-up period, including * A safety follow-up period: 28 days after the last dose of study drug; * Post-treatment follow-up visit: day 84 after the last dose of study drug; * Survival follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Subjects will be treated with HBM4003 and Toripalimap on Day 1 during each 21-day cycles.
Part1:Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration
Number of subjects who experience DLT events
Time frame: approximate 21 days
Part1:The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab
Time frame: approximate 21 days
Part1:Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab
Time frame: approximate 21 days
Part2:ORR, as determined by the Investigator using RECIST 1.1
Proportion of subjects with complete response (CR) and partial response (PR)
Time frame: maximum 2 years
Part 1:ORR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC
Proportion of patients with complete response (CR) and partial response (PR)
Time frame: maximum 2 years]
Part 1: Disease Control Rate, DCR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC
including proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD)
Time frame: maximum 2 years
Part 1: Duration of Response, DOR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC
Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Time frame: maximum 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part 1: Duration of Disease Control, DDC, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC
For subjects with Cr, PR or SD, the duration from the time of initial administration to the date of disease progression or death (for any reason) was calculated
Time frame: maximum 2 years
Part2: ORR, as determined by the Investigator using mRECIST for HCC
Proportion of patients with complete response (CR) and partial response (PR)
Time frame: maximum 2 years
Part 2: Disease Control Rate, DCR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC
including proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD)
Time frame: maximum 2 years
Part2: Duration of Response, DOR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC
Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Time frame: maximum 2 years
Part2:Duration of Disease Control, DDC, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC
For subjects with Cr, PR or SD, the duration from the time of initial administration to the date of disease progression or death (for any reason) was calculated
Time frame: maximum 2 years
Cmax
Peak Plasma Concentration
Time frame: maximum 2 years
Tmax
Time to reach maximum serum concentration
Time frame: maximum 2 years
AUC0-last
Area under the plasma concentration versus time curve from time zero to last
Time frame: maximum 2 years
AUC0-tau
Area under the serum concentration versus time curve from time zero to the dosing interval tau
Time frame: maximum 2 years
The immunogenicity of HBM4003 and Triprilimab
Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) was analyzed.
Time frame: maximum 2 years
Part 2: Overall survival (OS)
the length of time from the start of treatment to the death of the subject (for any reason)
Time frame: maximum 2 years
Part 2: Progression-free survival (PFS)
the length of time from the beginning of treatment to the beginning of disease progression or death (for any reason)
Time frame: maximum 2 years