Recruiting
Phase 2

APG-115 & APG-2575

Sponsor:

Ascentage Pharma Group Inc.

Code:

NCT04496349

Conditions

T-Prolymphocytic Leukemia

Non-Hodgkins Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

APG-115

APG-2575

Study Details

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.

Conditions

T-Prolymphocytic Leukemia

Non-Hodgkins Lymphoma

Study ID

NCT04496349

Start date

Jul 12, 2021

Status verified date

Nov, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: APG-115 monotherapy part

APG-115 will be given alone

experimental: APG-115 + APG-2575 combination dose escalation part

APG-115 is given in combination with APG-2575

experimental: APG-115 + APG-2575 combination dose expansion part

APG-115 is given in combination with APG-2575

Interventions

APG-115

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

APG-2575

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

Primary outcome measure

  • Maximum tolerated dose of APG-115 [ Time Frame: 21 days ]
  • Maximum tolerated dose of APG-115+APG-2575 [ Time Frame: 21 days ]

Central Contacts and Locations

Locations

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Tapan Kadia, MD

More Information

Sponsor

Ascentage Pharma Group Inc.

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ascentage Pharma Group Inc. on 2025-11-04.