Advanced Solid Tumor Clinical Trial
Official title:
An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor
To evaluate the safety,tolerability,pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor
Status | Recruiting |
Enrollment | 180 |
Est. completion date | July 30, 2023 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Hengrui Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) of HR19024 | 21-day cycle (tri-weekly) | ||
Secondary | Response rate (RR) | up to 6 months following the date the last patient was randomized | ||
Secondary | Disease Control Rate | up to 6 months following the date the last patient was randomized | ||
Secondary | Duration of Response | up to 6 months following the date the last patient was randomized | ||
Secondary | Progression free survival (PFS) | up to 6 months following the date the last patient was randomized |
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