NCT05222165

Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

A Phase 1b/2, Multicenter, Open-Label Study of Oral Infigratinib in Pediatric Subjects With Advanced Solid and Central Nervous System (CNS) Tumors (Phase 1b) and in Subjects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1, FGFR2, or FGFR3 Alterations (Phase 2)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

The phase 1b study is aimed at determining the pediatric recommended phase 2 dose (RP2D) of Infigratinib. The phase 2 study will evaluate efficacy and safety of infigratinib.

Detailed description

Phase 1b: Pediatric subjects with advanced solid and CNS tumors or recurrent or progressive Low-Grade Glioma with selected FGFR1-3 alterations will follow a standard dose escalation, in 3 dose levels, to determine the pediatric recommended Phase 2 dose (RP2D) and to assess the safety. Dose escalation decisions will be assessed through three dose level cohorts. Phase 2: To evaluate the efficacy and safety in Pediatric and adult subjects with LGG with selected FGFR1-3 alterations (including subjects who received infigratinib at the RP2D).

Conditions

• Advanced Solid Tumor
• CNS Tumor
• Recurrent WHO Grade II Glioma

Interventions

Type	Name	Description
DRUG	Infigratinib	Hard gelatin capsules for oral use

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2022-02-03
• Last updated: 2023-02-23

Locations

10 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated drug study