RecruitingPhase 1Phase 2NCT06306456

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

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral Administration of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With Advanced NSCLC With EGFR Mutations


Sponsor

Suzhou Genhouse Bio Co., Ltd.

Enrollment

94 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination treatment — the experimental drug GH21 combined with osimertinib (a standard targeted therapy) — in people with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR gene mutation and has stopped responding to previous targeted therapy. **You may be eligible if...** - You are 18 years or older - You have advanced NSCLC confirmed to have an EGFR mutation by biopsy or cytology - Your cancer has progressed after treatment with at least one third-generation EGFR-targeted drug (like osimertinib) - Your cancer has at least one measurable tumor on imaging **You may NOT be eligible if...** - You have not yet tried any EGFR-targeted therapy - Your cancer does not have an EGFR mutation - Your organ function or performance status does not meet the study requirements - You cannot consent or comply with the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGH21

Oral, 15mg BIW/6mg QD

DRUGTagrisso

Oral, 80mg QD


Locations(6)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06306456


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