A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
A Phase IIa Study Evaluating the Pharmacokinetics, Safety and Efficacy of APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With Relapsed/Refractory T-Cell Prolymphocytic Leukemia (R/R T-PLL) or Non-Hodgkin's Lymphoma (NHL).
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Jocelyn Budzynski
- Phone Number: 301-693-6952
- Email: jocelyn.budzynski@ascentage.com
Study Contact Backup
- Name: Genevieve Frank
- Phone Number: 301-802-3659
- Email: genevieve.frank@ascentage.com
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson
-
Contact:
- Kelly Quagliato
- Phone Number: 713-614-2069
- Email: krquagliato@mdanderson.org
-
Principal Investigator:
- Tapan Kadia, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Patients with relapsed/refractory T-PLL who have active disease and have received at least one prior therapy; Patients with histologically confirmed diagnosis of NHL, NHL Patients must be either relapsed, refractory, intolerant, or are considered ineligible for therapies known to provide clinical benefit;
- Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting APG-115 and/or APG-2575. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
- Absolute neutrophil count (ANC) ≥ 500/mm˄3; hemoglobin ≥ 60 g/L; platelet count ≥ 30,000/mm˄3
- Patients with adequate organ function;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his/her legally authorized representative is required prior to their enrollment on the protocol.
Exclusion Criteria:
- Patient previously treated with a murine double minute 2 (MDM2) inhibitor.
- Known active, uncontrolled central nervous system (CNS) malignancy
- Patients require graft versus host therapy, or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose of study drug).
- Patients who have any conditions or illness that, according to the opinions of the Investigators or the medical monitor, would compromise patient safety or interfere with the evaluation of safety and efficacy to the study drug(s).
- Patients who have used strong CYP2C8 inhibitors, or moderate or strong CYP3A4 inhibitors or inducers within washout period of 14 days or 7 half-lives before the first administration of study drugs, whichever is longer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: APG-115 monotherapy part
APG-115 will be given alone
|
QOD, 2 weeks on, 1 week off, in repeated 21-day cycles
|
|
Experimental: APG-115 + APG-2575 combination dose escalation part
APG-115 is given in combination with APG-2575
|
QOD, 2 weeks on, 1 week off, in repeated 21-day cycles
APG-2575 given orally each day in cycle, in repeated 21-day cycles
|
|
Experimental: APG-115 + APG-2575 combination dose expansion part
APG-115 is given in combination with APG-2575
|
QOD, 2 weeks on, 1 week off, in repeated 21-day cycles
APG-2575 given orally each day in cycle, in repeated 21-day cycles
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum tolerated dose of APG-115
Time Frame: 21 days
|
To evaluate the safety of APG-115 as a single agent
|
21 days
|
|
Maximum tolerated dose of APG-115+APG-2575
Time Frame: 21 days
|
To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination
|
21 days
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Yifan Zhai, MD, PhD, Ascentage Pharma Group Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma
- Leukemia, Lymphoid
- Leukemia
- Leukemia, T-Cell
- Hemic and Lymphatic Diseases
- Leukemia, Prolymphocytic
- Lymphoma, Non-Hodgkin
- Leukemia, Prolymphocytic, T-Cell
- Lisaftoclax
Other Study ID Numbers
Other Study ID Numbers
- APG115TU101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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