drugset / Trial / NCT06306456

A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

NCT06306456

Phase 1/2 Recruiting 94 enrolled Suzhou Genhouse Bio Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.

Timeline

Start
2024-03-05
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject GH21 Unknown 6 mg Oral
Subject GH21 Unknown 15 mg Oral
Subject Osimertinib Small molecule 80 mg Oral