drugset
drugset / Trial / NCT06975618

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)

NCT06975618 ↗

Phase 1/2 Recruiting 141 enrolled Haihe Biopharma Co., Ltd.
RandomizedSingle-groupOpen-labelTreatment

Summary

This study is a multi-center, open-label, single arm, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 in patients with PIK3CA-related overgrowth spectrum (PROS) and PIK3CA-related vascular malformations (PRVM)

Timeline

Start
2023-08-22
Primary completion
2029-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject RISOVALISIB Small molecule 5 mg Oral
Subject RISOVALISIB Small molecule 10 mg Oral

Indications

PIK3CA-related overgrowth spectrum vascular malformation