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This trial is an open-label, multi-center, dose escalation, dose expansion, and cohort expansion phase I/II clinical study of SYHX1903 in patients with relapsed/refractory hematologic malignancies. This trial aims to evaluate the safety, tolerance, pharmacokinetics, and preliminary antitumor activity of SYHX1903 in patients with relapsed/refractory hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL. |
|
| Arm 2 | Experimental | Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYHX1903 | Drug | SYHX1903 tablets, orally, qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities | DLTs will be determined from monitoring adverse events (AEs), and abnormal laboratory tests (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs (blood pressure and pulse), and electrocardiogram (ECG). | 28 days |
| Incidence of adverse events | Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters | 1 year |
| Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR) | To assess proportion of patients with anti tumor response to SYHX1903. response assessment by Cheson (2014) criteria and myeloma (Palumbo 2014) Response will be evaluated every 4-12 weeks (based on disease type) until progression | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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