NCT05701306

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part 1: Dose escalation and expansion of APG-115 monotherapy in pediatric neuroblastoma or solid tumors to determine MTD and recommended phase 2 dose, RP2D. Part 2: Dose escalation of APG-2575 to determine the MTD and RP2D combined with APG-115 at the dose level determined in part 1 in pediatric neuroblastoma or solid tumor, and extend the RP2D level of the combination therapy.

Conditions

• Neuroblastoma
• Solid Tumor

Interventions

Type	Name	Description
DRUG	APG-115	Orally once every other day(QOD) for 2 weeks and suspended for 1 week, 21 days as a cycle.
DRUG	APG-2575	Orally once a day (QD) for 21 days, 21 days as a cycle.

Timeline

• Start date: 2023-02-28
• Primary completion: 2026-06-01
• Completion: 2027-12-31
• First posted: 2023-01-27
• Last updated: 2025-02-25

Locations

3 sites across 1 country: China