Treatment of recurrent or refractory neuroblastoma in children with APG-115 and APG-2575

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I trial evaluates the safety and initial efficacy of APG-115 alone and in combination with APG-2575 in children with recurrent or refractory neuroblastoma or solid tumors. The study consists of two parts: the first part focuses on dose escalation of APG-115 to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The second part involves dose escalation of APG-2575 in combination with APG-115 to establish the MTD and RP2D for the combination therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥5 years for APG-115 monotherapy; age ≥12 years for APG-115 + APG-2575 combination.
2. Relapsed or refractory neuroblastoma or solid tumors with no available or suitable standard therapy.
3. Physical state score ≥ 50.
4. Expected survival ≥ 3 months.
5. There are target lesions (neuroblastoma) or measurable lesions (other solid tumors).
6. Have adequate organ function.
7. 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.
8. 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.
9. 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).
10. 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.
11. The ability to swallow research drugs.

Exclusion Criteria:

1. Received biological therapy, chemotherapy, or other investigational drugs within 21 days prior to dosing.
2. Received radiotherapy, minor surgery/minimally-invasive surgery; small-molecule targeted agents, short-half-life chemotherapeutic agents, or traditional Chinese medicines with anti-tumor indications within 14 days prior to study drug administration (or within 5 half-lives, whichever is shorter).
3. Patients who, according to the investigators' judgment, did not recover sufficiently after surgical treatment. Patients who underwent major surgery within 21 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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Tongji Hospital, Huazhong University of Science and Technology (HUST)
  Wuhan, Hubei, China Recruiting
• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Yizhuo Zhang — Sun Yat-Sen University Cancer Center
• Study coordinator: Yifan Zhai, MD,PHD
• Email: Yzhai@ascentage.com
• Phone: +86-20-28068501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.