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The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.
This is a phase IIa, open-label, multi-center, clinical trial of interfering the binding of MDM2 oncoprotein with the tumor suppressor P53 protein, leads to increased P53 and P21 protein expression and activates P53-mediated apoptosis. The hypothesis is that APG-115 monotherapy and in combination with APG-2575 will shows good safety and efficacy in patients with R/R T-PLL and NHL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APG-115 monotherapy part | Experimental | APG-115 will be given alone |
|
| APG-115 + APG-2575 combination dose escalation part | Experimental | APG-115 is given in combination with APG-2575 |
|
| APG-115 + APG-2575 combination dose expansion part | Experimental | APG-115 is given in combination with APG-2575 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APG-115 | Drug | QOD, 2 weeks on, 1 week off, in repeated 21-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of APG-115 | To evaluate the safety of APG-115 as a single agent | 21 days |
| Maximum tolerated dose of APG-115+APG-2575 | To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genevieve Frank | Contact | 301-802-3659 | genevieve.frank@ascentage.com | |
| Jocelyn Budzynski | Contact | 301-693-6952 | jocelyn.budzynski@ascentage.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifan Zhai, MD, PhD | Ascentage Pharma Group Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D015461 | Leukemia, Prolymphocytic, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015463 | Leukemia, Prolymphocytic |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000726452 | Lisaftoclax |
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The study consists of Part 1 APG-115 as monotherapy. Part 2 APG-2575 in combination with APG-115 dose escalation and APG-2575 in combination with APG-115 dose expansion phase. APG-115 and APG-2575 will be orally administrated on 21-day cycles. Patients will receive APG-115 QOD, 2 weeks on, 1 week off, and APG-2575 QD, in repeated 21-day cycles.
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| APG-2575 | Drug | APG-2575 given orally each day in cycle, in repeated 21-day cycles |
|
| D009369 |
| Neoplasms |
| D015458 | Leukemia, T-Cell |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |