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Trial Title:
APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
NCT ID:
NCT05701306
Condition:
Neuroblastoma
Solid Tumor
Conditions: Official terms:
Neuroblastoma
Conditions: Keywords:
Neuroblastoma
Solid Tumor
APG-115
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
APG-115
Description:
Orally once every other day(QOD) for 2 weeks and suspended for 1 week, 21 days as a
cycle.
Arm group label:
APG-115 combined with APG-2575 in part2
Arm group label:
APG-115 monotherapy in part1
Intervention type:
Drug
Intervention name:
APG-2575
Description:
Orally once a day (QD) for 21 days, 21 days as a cycle.
Arm group label:
APG-115 combined with APG-2575 in part2
Summary:
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.
Detailed description:
Part 1: Dose escalation and expansion of APG-115 monotherapy in pediatric neuroblastoma
or solid tumors to determine MTD and recommended phase 2 dose, RP2D.
Part 2: Dose escalation of APG-2575 to determine the MTD and RP2D combined with APG-115
at the dose level determined in part 1 in pediatric neuroblastoma or solid tumor, and
extend the RP2D level of the combination therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Recurrent or refractory neuroblastoma or solid tumor.
2. Physical state score ≥ 50.
3. Expected survival ≥ 3 months.
4. There are target lesions (neuroblastoma) or measurable lesions (other solid tumors).
5. Have adequate organ function.
6. Fresh or archived tumor tissue samples should be provided prior to treatment. If
none of these specimens are available, inclusion may be made after consultation with
the sponsor.
7. Fertile women (≥14 years of age or having menarche) must have a negative serum
pregnancy test at the time of the screening visit and must not be breastfeeding or
planning to become pregnant during the study period.
8. A potentially fertile male subject (who has spermatoses) or female subject (ibid.)
must agree to use effective contraception during the trial period and for 3 months
after the trial ends (or is prematurely discontinued).
9. Informed consent must be obtained before carrying out any study procedure specified
in the test. For child subjects, the consent of the subject and one of the
parent/legal guardian must be obtained.
10. The ability to swallow research drugs.
Exclusion Criteria:
1. 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.
2. 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.
3. 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.
4. 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).
5. Patients with active brain tumors or brain metastases.
6. Active gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis, or short
bowel syndrome) or other malabsorption syndromes that may affect drug absorption.
7. A known hemorrhagic predisposition/disease, such as a history of
non-chemotherapy-induced thrombocytopenic bleeding within 1 year before first
receiving the study drug; Have active immune thrombocytopenic purpura (ITP), active
autoimmune hemolytic anemia (AIHA), or a history of platelet transfusion failure
(within 1 year before first receiving the study drug); Severe gastrointestinal
bleeding occurred within 3 months.
8. Clinically significant cardiovascular disease, cardiomyopathy, myocardial infarction
or history within 6 months prior to administration.
9. Symptomatic active fungal, bacterial, and/or viral infections requiring systemic
treatment.
10. Unexplained fever > 38.5℃ within 2 weeks prior to initial administration (subjects
with tumor-related fever, as determined by the investigator, could be enrolled).
11. Received MDM2 inhibitors or BCL-2 inhibitors.
12. Any other circumstances or conditions that the investigator considers the patient
inappropriate for participation in the study.
Gender:
All
Minimum age:
12 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yizhuo Zhang, Ph.D.
Investigator:
Last name:
Yizhuo Zhang, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Tongji Hospital, Huazhong University of Science and Technology (HUST)
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Aiguo Liu, Ph.D.
Investigator:
Last name:
Aiguo Liu, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Zhao, Ph.D.
Investigator:
Last name:
Qiang Zhao, Ph.D.
Email:
Principal Investigator
Start date:
February 28, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Ascentage Pharma Group Inc.
Agency class:
Industry
Collaborator:
Agency:
Suzhou Yasheng Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Ascentage Pharma Group Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701306
