Solid Tumors
Conditions
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.
Interventions
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.
Sponsors
Harbour BioMed (Guangzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion/
Exclusion criteria
Main inclusion criteria 1. Males or females aged ≥ 18 years at the time of signing the informed consent form. For Part 1 of this study, the subjects should be ≤ 75 years of age. 2. For Part 1 of the study, patients histopathologically diagnosed with advanced or recurrent solid tumors 3. For Part 2 of the study, patients with locally advanced or metastatic melanoma who had been pathologically confirmed and could not be surgically removed were enrolled. 4. Subjects must be able to provide fresh or archived tumor tissues . 5. Patients whose estimated survival time is more than 3 months. 6. Patients with at least one measurable lesion at baseline according to RECIST (Version 1.1). 7. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. 8. Patients whose organ function must meet the study requirements: 9. Every woman or man with potential fertility needs to use an effective contraceptive method. Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| Part 2:ORR | maximum 3 years | Proportion of patients with complete response (CR) and partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum serum concentration) | maximum 3 years | Cmax |
| Tmax (Time to reach maximum serum concentration) | maximum 3 years | Tmax |
| 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 |
| 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 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 |
| 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 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; |
| 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 2:DCR | maximum 3 years | Proportion of patients with CR, PR and SD |
| Part 1:Disease Control Rate，DCR | maximum 3 years | Including complete response (CR),partial response (PR) and disease stability (SD) |
| 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) |
| 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 |
Contacts
Primary ContactWangnan ZHOU, Master
Backup ContactPeter ZHAO
Outcome results
None listed