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This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1702 monotherapy | Experimental | SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1702 | Drug | SHR-1702 monotherapy, administered IV |
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| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients | 2 years | |
| Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood disease hospital of Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300041 | China |
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| 2 years |
| Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS | 2 years |
| Immunogenicity as assessed by the presence of anti-drug antibodies | Anti SHR-1702 antibodies will be tested frequently | 2 years |
| Pharmacodynamic profile as assessed by receptor occupancy | SHR-1702 receptor occupation | 2 years |
| Objective response rate(ORR)for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006 | 2 years |
| Best of Response(BOR)for SHR-1702 in AML or high risk MDS | 2 years |
| Progression-Free Survival(PFS) for SHR-1702 in AML or high risk MDS | 2 years |
| Overall Survival(OS) for SHR-1702 in AML or high risk MDS | 2 years |