An Open-Label, Phase 1 Clinical Study 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
Overview
- Phase
- Phase 1
- Intervention
- HBM4003 and Triprilimab
- Conditions
- Solid Tumors
- Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Enrollment
- 67
- Primary Endpoint
- Part1:Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
HBM4003+Toripalimap
HBM4003 combined with toripalimab in patients with advanced HCC and other solid tumors
Intervention: HBM4003 and Triprilimab
Outcomes
Primary Outcomes
Part1:Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration
Time Frame: approximate 21 days
Number of subjects who experience DLT events
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
Time Frame: maximum 2 years
Proportion of subjects with complete response (CR) and partial response (PR)
Secondary Outcomes
- 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)
- Part2: Duration of Response, DOR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Part 2: Progression-free survival (PFS)(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(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(maximum 2 years)
- Tmax(maximum 2 years)
- AUC0-tau(maximum 2 years)
- Part 2: Overall survival (OS)(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(maximum 2 years)
- Part2: ORR, as determined by the Investigator using mRECIST for HCC(maximum 2 years)
- Part 2: Disease Control Rate, DCR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Cmax(maximum 2 years)
- AUC0-last(maximum 2 years)
- Part2:Duration of Disease Control, DDC, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- The immunogenicity of HBM4003 and Triprilimab(maximum 2 years)