Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab
- Conditions
- Solid Tumors
- Interventions
- Drug: HBM4003 and Triprilimab
- Registration Number
- NCT04727164
- Lead Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HBM4003+Toripalimap HBM4003 and Triprilimab HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors
- Primary Outcome Measures
Name Time Method Prat 1 :MTD approximate 42 days The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab
Prat 1 :RP2D approximate 42 days Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab
Part 2:ORR maximum 3 years Proportion of patients with complete response (CR) and partial response (PR)
Part 1:Number of subjects with DLT in each dose group within 2 cycles (42 days) after the first trial administration approximate 42 days 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).
- Secondary Outcome Measures
Name Time Method AUC0-last maximum 3 years AUC0-last
AUC0-tau (Area under the serum concentration versus time curve from time zero to the dosing interval tau maximum 3 years AUC0-tau
Part 2:DCR maximum 3 years Proportion of patients with CR, PR and SD
The immunogenicity of HBM4003 and Triprilimab maximum 3 years Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) was analyzed.
Prat 2:OS maximum 3 years The length of time from the beginning of treatment to the death of the subject (for any reason)
Part 1:Duration of Response, DOR maximum 3 years Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Cmax (Maximum serum concentration) maximum 3 years Cmax
Tmax (Time to reach maximum serum concentration) maximum 3 years Tmax
Prat 2:The immunogenicity of HBM4003 and Triprilimab maximum 3 years Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) was analyzed.
Part 1:ORR maximum 3 years Proportion of patients with complete response (CR) and partial response (PR)
Part 1:Disease Control Rate，DCR maximum 3 years Including complete response (CR),partial response (PR) and disease stability (SD)
Part 1:Duration of Disease Control, DDC maximum 3 years 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
Part 2:DOR maximum 3 years Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Part 2:DDC maximum 3 years 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
Part 2:PFS maximum 3 years The length of time from the beginning of treatment to the onset of disease progression or (for any reason) death;