An Open-label, Multicenter Phase Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivonescimab (AK112) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with Ivonescimab (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.
• Willing and able to provide written informed consent for this trial.
• At the time of screening, aged ≥18 years and ≤75 years.
• Histologically or cytologically confirmed locally advanced (Stage IIIB/III C) or metastatic (Stage IV) NSCLC that is not amenable to complete surgical resection and cannot be treated with curative concurrent or sequential chemoradiotherapy (according to the 8th edition of the International Union Against Cancer and the American Joint Committee on Cancer TNM staging for lung cancer).
• Stage Ib: Locally advanced/metastatic NSCLC; both subjects who have previously received systemic therapy and those who have not may be enrolled;
• Phase II: Each cohort must meet the following requirements:
• Cohort 1: Histologically or cytologically diagnosed with non-squamous NSCLC, EGFR wild-type, and ALK fusion-negative.
• Co-hort 2: Histologically or cytologically diagnosed with squamous-cell NSCLC, known to be EGFR wild-type and ALK fusion gene-negative.
• Co-hort 3: Histologically or cytologically diagnosed with non-squamous NSCLC and harboring an EGFR mutation.
• Subjects must have at least one measurable lesion (as defined by RECIST 1.1 criteria).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected survival of ≥12 weeks.
• Subjects' laboratory test results must meet the requirements.
• Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP
⁃ Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (IMP).
⁃ Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
⁃ Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.