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Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation of VIP943 (QW) | Experimental | Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW). |
|
| Dose Escalation of VIP943 (BIW) | Experimental | Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIP943 (QW) | Drug | VIP943 will be administered by IV Infusion weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLT (Dose limit toxicity) of VIP943 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate to VIP943 as assessed by investigators using disease-specific response criteria | Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months) | |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincerx Clinical Trials Contact | Contact | 16508006676 | clinicaltrials@vincerx.com |
| Name | Affiliation | Role |
|---|---|---|
| Vincerx Study Director | Vincerx Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D002051 | Burkitt Lymphoma |
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D001855 | Bone Marrow Diseases |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
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Sequential Assignment
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| VIP943 (BIW) |
| Drug |
VIP943 will be administered by IV Infusion bi-weekly |
|
| Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days |
| Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943 | Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days |
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| TriStar Bone Marrow Transplant | Recruiting | Nashville | Tennessee | 37203 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| D020031 |
| Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |