[Translation] A phase I, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, and efficacy of intravenous HY1272 in patients with locally advanced or metastatic EGFRm+ non-small cell lung cancer.
主要目的:HY1272静脉给药在局部晚期或转移性表皮生长因子受体敏感突变阳性(EGFRm+)非小细胞肺癌(NSCLC)患者中的安全性、耐受性。
次要目的是:1) 确定HY1272单独给药的剂量限制性毒性(DLT)、最大耐受剂量(MTD)和推荐II期剂量(RP2D)。 2) 评价HY1272单次给药后和多次给药后稳态时的免疫原性。3) 评价HY1272单次给药后和多次给药后的药代动力学。4)初步评估HY1272的抗肿瘤效果
探索性目的: 1) 在适当情况下,探索PK与选定终点(可能包括生物标志物)之间的关系。 2)采集和储存诊断性肿瘤样本和任何新鲜肿瘤活检样本以用于将来可能进行的探索性研究,此类研究可能与NSCLC的发展和/或HY1272的抗肿瘤活性反应有关。
[Translation] Primary Objective: To assess the safety and tolerability of intravenous HY1272 in patients with locally advanced or metastatic epidermal growth factor receptor-sensitive mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC).
Secondary Objectives:
1) To determine the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of HY1272 monotherapy.
2) To evaluate the immunogenicity of HY1272 at steady state after a single and multiple doses.
3) To evaluate the pharmacokinetics of HY1272 after a single and multiple doses.
4) To preliminarily assess the antitumor efficacy of HY1272.
Exploratory Objectives:
1) To explore the relationship between PK and selected endpoints (which may include biomarkers), where appropriate.
2) To collect and store diagnostic tumor samples and any fresh tumor biopsy samples for future exploratory studies that may be related to the development of NSCLC and/or the antitumor activity response of HY1272.