APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-18
SponsorAscentage Pharma Group Inc.
About this trial
An open, non-randomized Phase I trial of dose-escalation and cohorts expansion to evaluate the safety, pharmacokinetic profile and initial efficacy of APG-115 alone or in combination with APG-2575 in the treatment of recurrent or refractory pediatric neuroblastoma or solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Recurrent or refractory neuroblastoma or solid tumor.
Physical state score ≥ 50.
Expected survival ≥ 3 months.
There are target lesions (neuroblastoma) or measurable lesions (other solid tumors).
Disqualifiers
Systemic antitumor therapy, including biotherapy, chemotherapy, surgery, radiotherapy, immunotherapy, and other investigational drug therapy (other than placebo), was received within 21 days prior to the first treatment with the study drug.
Small-molecule targeted drug therapy was administered 14 days before the first treatment of the study drug or within a known five-half-life period, whichever is shorter.
Patients who, according to the investigators' judgment, did not recover sufficiently after surgical treatment. Patients who underwent major surgery within 28 days before receiving the study drug for the first time.
Adverse events due to previous antitumor therapy (except grade 2 peripheral neurotoxicity and alopecia that the investigators judged to be of no safety risk) have not recovered (severity higher than grade 1 according to CTCAE version 5.0).
Trial design
Design model
Sequential
Treatments tested in this trial
APG-115
DrugOrally once every other day(QOD) for 2 weeks and suspended for 1 week, 21 days as a cycle.
APG-2575
DrugOrally once a day (QD) for 21 days, 21 days as a cycle.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: APG-115 monotherapy in part1Experimental treatment 1 intervention
Group B: APG-115 combined with APG-2575 in part2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (Phase I)
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 3 weeks of study treatment. These will be assessed via CTCAE version 5.0.
Time frame
Up to 21 days2
Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0
Number of patients with adverse event; Number of patients with abnormal vital signs, abnorma physical examination, laboratory abnormalities, and abnormal 12-lead ECG in monotherapy of APG-115 and combined with APG-2575.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ascentage Pharma Group Inc.
Lead sponsor
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov