NCT05701306 APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
| NCT ID | NCT05701306 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ascentage Pharma Group Inc. |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2023-02-28 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Yizhuo Zhang
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT05701306 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05701306 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05701306 currently recruiting?
Yes, NCT05701306 is actively recruiting participants. Contact the research team at Yzhai@ascentage.com for enrollment information.
Where is the NCT05701306 trial being conducted?
This trial is being conducted at Guangzhou, China, Wuhan, China, Tianjin, China.
Who is sponsoring the NCT05701306 clinical trial?
NCT05701306 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Yizhuo Zhang at Sun Yat-sen University. The trial plans to enroll 100 participants.