T-Prolymphocytic LeukemiaPhase 2NCT04496349
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 2 study testing APG-115 and APG-2575 in people with T-Prolymphocytic Leukemia and Non-Hodgkins Lymphoma, run by Ascentage Pharma Group Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-Prolymphocytic Leukemia, Non-Hodgkins Lymphoma
- What is being tested?
- APG-115 and APG-2575
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson
Houston, Texas, 77030
Kelly Quagliato, 713-614-2069, krquagliato@mdanderson.org
Tapan Kadia, MD
About this study
Official title: 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).
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.
Read the 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
- Being tested
- APG-115, APG-2575
- Medical subject headings
- Leukemia, Prolymphocytic, T-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-115Drug
QOD, 2 weeks on, 1 week off, in repeated 21-day cycles
APG-2575Drug
APG-2575 given orally each day in cycle, in repeated 21-day cycles
| Study group | Role | What they receive |
|---|---|---|
| APG-115 monotherapy part | Experimental | APG-115 will be given alone Receives: Drug: APG-115 |
| APG-115 + APG-2575 combination dose escalation part | Experimental | APG-115 is given in combination with APG-2575 Receives: Drug: APG-115; Drug: APG-2575 |
| APG-115 + APG-2575 combination dose expansion part | Experimental | APG-115 is given in combination with APG-2575 Receives: Drug: APG-115; Drug: APG-2575 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of APG-115
To evaluate the safety of APG-115 as a single agent
Measured: 21 days
Maximum tolerated dose of APG-115+APG-2575
To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start12 Jul 2021
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Prolymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifan Zhai, MD, PhD, Study chair, Ascentage Pharma Group Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496349
- Sponsor's protocol ID
- APG115TU101
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2020
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT04496349
- Acronym / sponsor ID
- APG115TU101
- Conditions
- T-Prolymphocytic Leukemia, Non-Hodgkins Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| APG-115 monotherapy part | Experimental | Drug: APG-115APG-115 will be given alone |
| APG-115 + APG-2575 combination dose escalation part | Experimental | Drug: APG-115, Drug: APG-2575APG-115 is given in combination with APG-2575 |
| APG-115 + APG-2575 combination dose expansion part | Experimental | Drug: APG-115, Drug: APG-2575APG-115 is given in combination with APG-2575 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-115QOD, 2 weeks on, 1 week off, in repeated 21-day cycles | Drug | APG-115 + APG-2575 combination dose escalation part, APG-115 + APG-2575 combination dose expansion part, APG-115 monotherapy part |
| APG-2575APG-2575 given orally each day in cycle, in repeated 21-day cycles | Drug | APG-115 + APG-2575 combination dose escalation part, APG-115 + APG-2575 combination dose expansion part |
Primary outcome
Maximum tolerated dose of APG-115
Time frame: 21 days
To evaluate the safety of APG-115 as a single agent
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yifan Zhai, MD, PhD study chair
Ascentage Pharma Group Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APG-115 and APG-2575 in people with T-Prolymphocytic Leukemia and Non-Hodgkins Lymphoma, run by Ascentage Pharma Group Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Genevieve Frank (301-802-3659, genevieve.frank@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of APG-115 (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.