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This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1909 monotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1909 injection | Drug | SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)). |
| Measure | Description | Time Frame |
|---|---|---|
| MTD of SHR-1909 | Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs) | From Day 1 to 4 weeks |
| RP2D of SHR-1909 | Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data. | From Day 1 to 90 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse Events documented by CTCAE 5.0 | 90 days after the last dose |
| Objective Response Rate (ORR) | Baseline to documented disease progression or study discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Cancer Hospital | Changchun | Jilin | 130000 | China |
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Dose escalation (non randomized, 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)
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| Up to approximately 2 years |
| Progression-Free Survival (PFS) | From Day 1 to Radiographic Progression or Death Due to Any Cause | Up to approximately 2 years |