A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL

NCT ID: NCT04496349

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2027-05-31

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.

Detailed Description

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

Conditions

T-Prolymphocytic Leukemia; Non-Hodgkins Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APG-115 monotherapy part

APG-115 will be given alone

Group Type: EXPERIMENTAL

APG-115

Intervention Type: DRUG

QOD, 2 weeks on, 1 week off, in repeated 21-day cycles

APG-115 + APG-2575 combination dose escalation part

APG-115 is given in combination with APG-2575

Group Type: EXPERIMENTAL

APG-115

Intervention Type: DRUG

QOD, 2 weeks on, 1 week off, in repeated 21-day cycles

APG-2575

Intervention Type: DRUG

APG-2575 given orally each day in cycle, in repeated 21-day cycles

APG-115 + APG-2575 combination dose expansion part

APG-115 is given in combination with APG-2575

Group Type: EXPERIMENTAL

APG-115

Intervention Type: DRUG

QOD, 2 weeks on, 1 week off, in repeated 21-day cycles

APG-2575

Intervention Type: DRUG

APG-2575 given orally each day in cycle, in repeated 21-day cycles

Interventions

APG-115

QOD, 2 weeks on, 1 week off, in repeated 21-day cycles

Intervention Type: DRUG

APG-2575

APG-2575 given orally each day in cycle, in repeated 21-day cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old

2. 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;

3. 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.

4. Absolute neutrophil count (ANC) ≥ 500/mm˄3; hemoglobin ≥ 60 g/L; platelet count ≥ 30,000/mm˄3

5. Patients with adequate organ function;

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

7. 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

1. Patient previously treated with a murine double minute 2 (MDM2) inhibitor.

2. Known active, uncontrolled central nervous system (CNS) malignancy

3. 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).

4. 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).

5. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascentage Pharma Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yifan Zhai, MD, PhD

Role: STUDY_CHAIR

Ascentage Pharma Group Inc.

Locations

MD Anderson

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Genevieve Frank

Role: CONTACT

genevieve.frank@ascentage.com

301-802-3659

Jocelyn Budzynski

Role: CONTACT

jocelyn.budzynski@ascentage.com

301-693-6952

Facility Contacts

Kelly Quagliato

Role: primary

krquagliato@mdanderson.org

713-614-2069

Other Identifiers

APG115TU101

Identifier Type: -

Identifier Source: org_study_id