[Translation] Phase II clinical study to evaluate the efficacy and safety of SI-B003 single drug and BL-B01D1+SI-B003 double drug therapy in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal system tumors
1)主要目的:探索SI-B003单药及BL-B01D1+SI-B003双药在局部晚期或转移性食管癌、胃癌、结直肠癌等消化道系统肿瘤患者中的有效性。探索SI-B003单药及BL-B01D1+SI-B003双药在局部晚期或转移性食管癌、胃癌、结直肠癌等消化道系统肿瘤患者中的安全性和耐受性,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、SI-B003的药代动力学。探索BL-B01D1、SI-B003的免疫原性。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) Main purpose: To explore the effectiveness of SI-B003 single drug and BL-B01D1+SI-B003 double drug in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal system tumors. Explore the safety and tolerability of SI-B003 single drug and BL-B01D1+SI-B003 double drug in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal system tumors, and further explore the combination optimal dosage and form. 2) Secondary purpose: To explore the pharmacokinetics of the drugs BL-B01D1 and SI-B003. Explore the immunogenicity of BL-B01D1 and SI-B003. Explore drug-drug interactions (DDIs). 3) Exploratory purposes: To explore the relationship of potential predictive, prognostic biomarkers to disease state, study treatment response, including archived and/or obtained before and/or after completion of study treatment, and/or disease progression Biomarker levels in fresh tumor tissue and blood samples, such as EGFR, HER3, TMB, PD-L1, etc.