A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combine With Toripalimab in Patients With Advanced HCC and Other Solid Tumors
- Conditions
- Solid Tumors
- Interventions
- Drug: HBM4003 and Triprilimab
- Registration Number
- NCT05149027
- Lead Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 67
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 HCC and other solid tumors
- Primary Outcome Measures
Name Time Method Part1:Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration approximate 21 days Number of subjects who experience DLT events
Part1:The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab approximate 21 days Part1:Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab approximate 21 days Part2:ORR, as determined by the Investigator using RECIST 1.1 maximum 2 years Proportion of subjects with complete response (CR) and partial response (PR)
- Secondary Outcome Measures
Name Time Method 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 maximum 2 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
Part2: Duration of Response, DOR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC maximum 2 years Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Part 2: Progression-free survival (PFS) maximum 2 years the length of time from the beginning of treatment to the beginning of disease progression or death (for any reason)
Part 1:ORR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC maximum 2 years] Proportion of patients with complete response (CR) and partial response (PR)
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 maximum 2 years including proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD)
Tmax maximum 2 years Time to reach maximum serum concentration
AUC0-tau maximum 2 years Area under the serum concentration versus time curve from time zero to the dosing interval tau
Part 2: Overall survival (OS) maximum 2 years the length of time from the start of treatment to the death of the subject (for any reason)
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 maximum 2 years Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason)
Part2: ORR, as determined by the Investigator using mRECIST for HCC maximum 2 years Proportion of patients with complete response (CR) and partial response (PR)
Part 2: Disease Control Rate, DCR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC maximum 2 years including proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD)
Cmax maximum 2 years Peak Plasma Concentration
AUC0-last maximum 2 years Area under the plasma concentration versus time curve from time zero to last
Part2:Duration of Disease Control, DDC, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC maximum 2 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
The immunogenicity of HBM4003 and Triprilimab maximum 2 years Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) was analyzed.