RecruitingPhase 1Phase 2NCT05701306

APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors

A Phase Ib-ⅡClinical Study of APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors


Sponsor

Ascentage Pharma Group Inc.

Enrollment

100 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

An open, non-randomized Phase Ib-II 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 neuroblastoma or solid tumors.


Eligibility

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study tests APG-115 — a drug that reactivates the body's natural cancer-fighting protein (p53) — alone or combined with APG-2575 (a drug that blocks cancer cell survival signals) in children with neuroblastoma or other solid tumors that have returned or stopped responding to treatment. **You may be eligible if...** - Your child has relapsed or treatment-resistant neuroblastoma or another solid tumor - Your child has measurable or trackable areas of disease - Your child has adequate organ function - Your child has a performance score of 50 or higher (Lansky scale) - Expected survival is at least 3 months - Tumor tissue samples are available or can be obtained **You may NOT be eligible if...** - Your child has uncontrolled infection or severe organ failure - Your child is pregnant or breastfeeding, or a fertile female/male not willing to use contraception - Your child has received certain other investigational treatments recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-115

Orally once every other day(QOD) for 2 weeks and suspended for 1 week, 21 days as a cycle.

DRUGAPG-2575

Orally once a day (QD) for 21 days, 21 days as a cycle.


Locations(3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Tongji Hospital, Huazhong University of Science and Technology (HUST)

Wuhan, Hubei, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05701306


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