[Translation] Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in the treatment of patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma and other solid tumors
1)主要目的:探索BL-B01D1联合PD-1单抗在局部晚期或转移性非小细胞肺癌及鼻咽癌等实体瘤患者中的有效性、安全性和耐受性,并进一步探索联用的最佳剂量和方式。2)次要目的:探索研究药物BL-B01D1的药代动力学特征和免疫原性。探索药物-药物相互作用(DDI)。3)探索性目的:探索潜在的预测性、预后生物标志物与疾病状态、研究治疗应答的关系,包括在研究治疗前和/或治疗完成后、和/或疾病进展时获得的存档和/或新鲜肿瘤组织和血液样本中的生物标志物水平,如EGFR、HER3、TMB、PD-L1等。
[Translation] 1) Primary purpose: To explore the efficacy, safety and tolerability of BL-B01D1 combined with PD-1 monoclonal antibody in patients with solid tumors such as locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and method of combination. 2) Secondary purpose: To explore the pharmacokinetic characteristics and immunogenicity of the study drug BL-B01D1. To explore drug-drug interactions (DDI). 3) Exploratory purpose: To explore the relationship between potential predictive and prognostic biomarkers and disease status and study treatment response, including biomarker levels in archived and/or fresh tumor tissues and blood samples obtained before and/or after completion of study treatment and/or at disease progression, such as EGFR, HER3, TMB, PD-L1, etc.