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

Launched by ASCENTAGE PHARMA GROUP INC. · Jul 29, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called APG-115, which may help patients with two types of blood cancers: T-Prolymphocytic Leukemia (T-PLL) and Non-Hodgkin's Lymphoma (NHL). The researchers want to find out how safe and effective this medication is when used alone or together with another drug called APG-2575. They are currently recruiting adult patients aged 18 and older who have had at least one previous treatment for their condition and still have active disease. Participants should also meet certain health criteria, such as having enough healthy blood cells and proper organ function.

If you decide to participate, you can expect to receive treatment with the study drugs and be monitored for any side effects or changes in your health. It's important that you haven't had chemotherapy or specific antibody treatments for at least a week before starting the study. The trial will provide a thorough understanding of how well these medications work and their safety profile. If you or a loved one are interested, please talk to your healthcare provider to see if you might be eligible to join this study.

Gender

ALL

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.