A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
APG-115
DrugQOD, 2 weeks on, 1 week off, in repeated 21-day cycles
APG-2575
DrugAPG-2575 given orally each day in cycle, in repeated 21-day cycles
Treatment groups
78 Participants
are divided into 3 treatment groupsGroup A: APG-115 monotherapy partExperimental treatment 1 intervention
Group B: APG-115 + APG-2575 combination dose escalation partExperimental treatment 2 interventions
Group C: APG-115 + APG-2575 combination dose expansion partExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum tolerated dose of APG-115
To evaluate the safety of APG-115 as a single agent
Time frame
21 days2
Maximum tolerated dose of APG-115+APG-2575
To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination
Time frame
21 daysSponsors and contacts
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Source ClinicalTrials.gov