HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.
An open-label Phase 1 study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors. The study is composed of two part, part 1 will be approximately 31subjects and Part 2 will be approximately 30 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Subjects will be treated with HBM4003 on Day 1 Cycle 1 and be treated with HBM4003 and Triprilimab during each 21-day cycles from Cycle 2 in part 1.Subjects will be treated with HBM4003 and Triprilimab on Day 1 during each 21-day cycle in part 2.
Prat 1 :MTD
The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab
Time frame: approximate 42 days
Prat 1 :RP2D
Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab
Time frame: approximate 42 days
Part 1:Number of subjects with DLT in each dose group within 2 cycles (42 days) after the first trial administration
DLT observation period was defined as two treatment cycles with a total of 42 days,including 21 days in the first cycle (HBM4003 single drug treatment cycle) and 21 days in the second cycle (HBM4003 combined with triprilimab treatment cycle).
Time frame: approximate 42 days
Part 2:ORR
Proportion of patients with complete response (CR) and partial response (PR)
Time frame: maximum 3 years
Part 1:ORR
Proportion of patients with complete response (CR) and partial response (PR)
Time frame: maximum 3 years
Part 1:Disease Control Rate,DCR
Including complete response (CR),partial response (PR) and disease stability (SD)
Time frame: maximum 3 years
Part 1:Duration of Response, DOR
Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Time frame: maximum 3 years
Part 1:Duration of Disease Control, DDC
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 3 years
Cmax (Maximum serum concentration)
Cmax
Time frame: maximum 3 years
Tmax (Time to reach maximum serum concentration)
Tmax
Time frame: maximum 3 years
AUC0-last
AUC0-last
Time frame: maximum 3 years
AUC0-tau (Area under the serum concentration versus time curve from time zero to the dosing interval tau
AUC0-tau
Time frame: maximum 3 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 3 years
Part 2:DCR
Proportion of patients with CR, PR and SD
Time frame: maximum 3 years
Part 2:DOR
Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Time frame: maximum 3 years
Part 2:DDC
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 3 years
Prat 2:OS
The length of time from the beginning of treatment to the death of the subject (for any reason)
Time frame: maximum 3 years
Part 2:PFS
The length of time from the beginning of treatment to the onset of disease progression or (for any reason) death;
Time frame: maximum 3 years
Prat 2: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 3 years
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