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RecruitingPhase 2

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).

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests APG-115 alone or with APG-2575 for adults with T-cell prolymphocytic leukemia (T-PLL) or non-Hodgkin lymphoma (NHL), two types of blood cancer. It checks safety, how well treatment works, and how the body processes the drugs. It is for people whose cancer came back or did not respond to treatment, or whose NHL treatment options are not suitable.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old.
  • If you have T-PLL, it must be active and have come back or not responded after at least one treatment.
  • If you have NHL, it must be confirmed by a tissue test. It must have come back, not responded to treatment, or you must be unable to tolerate or receive treatments known to help.
  • You must have no chemotherapy or antibody treatment for 7 days before starting the study drugs. For fast-growing cancer, hydroxyurea or Decadron may be used until 24 hours before starting.
  • Your blood counts must meet these limits: neutrophils (infection-fighting cells) at least 500/mm³, hemoglobin (the oxygen-carrying part of blood) at least 60 g/L, and platelets (cells that help stop bleeding) at least 30,000/mm³.
  • Your organs must work well enough for the study.
  • You must be able to care for yourself and be up and about for at least half of your waking hours (ECOG score of 0–2).
  • You must understand the study requirements. You or your legal representative must sign a consent form before you join.

Who can't join

  • You have been treated with an MDM2 inhibitor, a type of drug that blocks the MDM2 protein.
  • You have known, active cancer in the brain or spinal cord that is not controlled.
  • You need treatment for graft-versus-host disease, when donated cells attack your body, or ongoing medicine that lowers immune activity throughout the body. This includes calcineurin inhibitors within 4 weeks before the first study dose.
  • The study doctor or medical monitor believes another illness or condition could make the study unsafe for you or affect how the study drugs are assessed.
  • You have recently taken certain medicines that change how the body processes drugs: strong CYP2C8 blockers, or moderate or strong CYP3A4 blockers or boosters. You must stop these for at least 14 days or 7 half-lives, whichever is longer. A half-life is the time it takes the body to clear half of a drug.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX