A Study of HR19024 in Subjects With Advanced Solid Tumor
Study Details
Study Description
Brief Summary
To evaluate the safety,tolerability,pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HR19024 Part 1: Dose escalation of HR19024 montherapy for advanced solid tumor Part 2:PK expansion of HR19024 montherapy for advanced solid tumor Part 3: Efficacy expansion of HR19024 montherapy for advanced solid tumor |
Drug: HR19024
Intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- Maximum tolerated dose (MTD) of HR19024 [21-day cycle (tri-weekly)]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ECOG performance status 0 or 1
-
Histologically confirmed advanced solid tumor
-
Life expectancy of greater than or equal to (>=) 12 weeks
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At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
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Able and willing to provide a written informed consent
Exclusion Criteria:
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Subjects with unresolved toxicity (> CTCAE G1)of prior therapy at the time of enrolment
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Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HR19024-101