RecruitingPhase 1NCT05701306

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

A Phase I Clinical Study of APG-115 Alone or in Combination With APG-2575 in Children With 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 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

Min Age: 12 YearsMax Age: 18 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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

For the most up-to-date information, visit the official listing.

Visit

NCT05701306


Related Trials