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
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.
• Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
• Male or female subjects aged ≥18 years;
• Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:
‣ Phase Ib: patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy;
⁃ Phase IIa and IIb:patients with disease progression previously at least treated with a third-generation EGFR-TKIs (Osimertinib, Furmonertinib Almonertinib etc.).
• Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);
• Consent to provide samples for genetic testing;
• Life expectancy of ≥ 3 months;
• ECOG PS score of 0-1;
• The subjects must have adequate organ functions;
• Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 30 days after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.