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).
1 other identifier
interventional
78
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
November 4, 2025
November 1, 2025
4.9 years
July 22, 2020
November 3, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
APG-115 monotherapy part
EXPERIMENTALAPG-115 will be given alone
APG-115 + APG-2575 combination dose escalation part
EXPERIMENTALAPG-115 is given in combination with APG-2575
APG-115 + APG-2575 combination dose expansion part
EXPERIMENTALAPG-115 is given in combination with APG-2575
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2020
First Posted
August 3, 2020
Study Start
July 12, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
November 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share