Actively Recruiting
APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
Led by Ascentage Pharma Group Inc. · Updated on 2025-02-25
100
Participants Needed
3
Research Sites
252 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
S
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
- Have adequate organ function.
- 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.
- 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.
- 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).
- 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.
- The ability to swallow research drugs.
You will not qualify if you...
- 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).
- Patients with active brain tumors or brain metastases.
- Active gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption syndromes that may affect drug absorption.
- 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.
- Clinically significant cardiovascular disease, cardiomyopathy, myocardial infarction or history within 6 months prior to administration.
- Symptomatic active fungal, bacterial, and/or viral infections requiring systemic treatment.
- Unexplained fever > 38.5℃ within 2 weeks prior to initial administration (subjects with tumor-related fever, as determined by the investigator, could be enrolled).
- Received MDM2 inhibitors or BCL-2 inhibitors.
- Any other circumstances or conditions that the investigator considers the patient inappropriate for participation in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Tongji Hospital, Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, China, 430030
Actively Recruiting
3
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Y
Yifan Zhai, MD,PHD
CONTACT
Y
Yan Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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