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This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK117+Azacitidine+Venetoclax | Experimental | Phase Ib: Subjects will receive: A117: different doses on every 2 weeks, azacitidine: 75 mg/m^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; Phase II: Subjects will receive: AK117: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter. |
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| Placebo+Azacitidine+Venetoclax | Placebo Comparator | Phase II: Subjects will receive: placebo: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK117 | Drug | Subjects receive AK117 intravenously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of participants with dose limiting toxicity (DLT) | Any untoward medical occurrence in a subject within the first cycle, considered related to the study treatment | At the end of Cycle 1 (each cycle is 28 days) |
| Phase 1b/2: Number of participants with adverse events (AEs) | Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment | Up to approximately 2 years. |
| Phase 1b/2: Composite complete remission rate (CCR) | The proportion of subjects achieving complete remission (CR) , complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2022 criteria | Time Frame: Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of subjects with recorded response per European LeukemiaNet (ELN) 2022 | Up to approximately 2 years |
| Time to response (TTR) | Time from cycle 1 day 1(C1D1) to the first recorded response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Yang, MD | Contact | +86(0760)89873999 | jie.yang@akdsobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Azacitidine |
| Drug |
Subjects receive azacitidine subcutaneously. |
|
| Venetoclax | Drug | Subjects receive venetoclax orally. |
|
| Placebo | Other | Subjects receive placebo intravenously. |
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| Up to approximately 2 years |
| Time to CCR (TTCCR) | Time from C1D1 to the first recorded CR, CRh or CRi | Up to approximately 2 years |
| Duration of response (DoR) | Time from the first recorded response until disease progression, relapse, or death due to any cause, whichever occurs first | Up to approximately 2 years |
| Duration of CCR (DoCCR) | Time from the first recorded CR, CRh or CRi until disease progression, relapse, or death due to any cause, whichever occurs first | Up to approximately 2 years |
| Rate of CCR Without Minimal Residual Disease (CCR MRD-) | The proportion of subjects achieving CR, CRh or CRi with MRD-negative status per ELN 2022 criteria. | Up to approximately 2 years |
| Event-free survival (EFS) | Time from C1D1 until disease progression, relapse, or death due to any cause, whichever occurs first | Up to approximately 2 years |
| Overall survival (OS) | Up to approximately 2 years | The time from C1D1 until death due to any cause |
| Peak of Serum Concentration (Cmax) | Maximal serum concentrations of AK117 in individual subjects at different time points after AK117 administration | Up to approximately 2 years |
| Anti-drug antibody (ADA) | Number of subjects with detectable anti-drug antibodies | Up to approximately 2 years |
| Receptor occupancy (RO) | CD47 occupancy rate on peripheral blood T cells and red blood cells before and after AK117 administration | Up to approximately 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |