Advanced Solid Tumor
Conditions
Brief summary
To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor
Interventions
DRUGHR19024
Intravenous infusion
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HR19024 for all enrolled subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ECOG performance status 0 or 1 2. Histologically confirmed advanced solid tumor 3. Life expectancy of greater than or equal to (\>=) 12 weeks 4. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1) 5. Able and willing to provide a written informed consent
Exclusion criteria
1. Subjects with unresolved toxicity （\> CTCAE G1）of prior therapy at the time of enrolment 2. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of HR19024 | 21-day cycle (tri-weekly) |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (RR) | up to 6 months following the date the last patient was randomized |
| Disease Control Rate | up to 6 months following the date the last patient was randomized |
| Duration of Response | up to 6 months following the date the last patient was randomized |
| Progression free survival (PFS) | up to 6 months following the date the last patient was randomized |
Countries
China
Outcome results
None listed