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

Solid Tumor Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05701306
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact Yifan Zhai, MD,PHD
Phone +86-20-28068501
Email Yzhai@ascentage.com
Status Recruiting
Phase Phase 1
Start date February 28, 2023
Completion date December 31, 2027
View Details
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