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New treatment option for Neuroblastoma
Official title APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
ClinicalTrials.gov ID: NCT05701306
What this study is testing
What is APG-115?
APG-115 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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.
You likely can't join if
- Systemic antitumor therapy, including biotherapy, chemotherapy, surgery, radiotherapy, immunotherapy, and other investigational drug therapy (other...
- 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...
- Patients who, according to the investigators' judgment, did not recover sufficiently after surgical treatment. Patients who underwent major surgery...
- Adverse events due to previous antitumor therapy (except grade 2 peripheral neurotoxicity and alopecia that the investigators judged to be of no...
- 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...
See the full eligibility criteria
- 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 people, the consent of the subject and one of the parent/legal guardian must be obtained.
- The ability to swallow research drugs.
- 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...
- 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...
- 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)...
- 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 (people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Wuhan, Hubei, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.