[Translation] A single-arm, open-label, multicenter Phase II clinical study to evaluate the safety and efficacy of TB01 in patients with advanced colorectal cancer
主要目的:
评价TB01在 晚期结直肠癌 患者中的 抗肿瘤效应 。
次要目的:
1) 评价 TB01在晚期 结直肠癌 患者中的药代动力学( PK)特征
2)评价 TB01在晚期 结直肠癌 患者中的 安全性及耐受性 。
探索性目的:
1) 探索肿瘤组织中整合素的表达情况与疾病预后的相关性;
2) 探索体内细胞因子及其受体(VEGF、VEGFR)在用药前后的变化及其与疾病预后的相关性;
3) 探索TB01在晚期结肠癌患者中的免疫原性及抗药抗体(ADA)产生对PK、有效性和安全性的影响。
[Translation] Primary purpose:
To evaluate the anti-tumor effect of TB01 in patients with advanced colorectal cancer.
Secondary purpose:
1) To evaluate the pharmacokinetic (PK) characteristics of TB01 in patients with advanced colorectal cancer
2) To evaluate the safety and tolerability of TB01 in patients with advanced colorectal cancer.
Exploratory purpose:
1) To explore the correlation between the expression of integrins in tumor tissues and disease prognosis;
2) To explore the changes of cytokines and their receptors (VEGF, VEGFR) in the body before and after medication and their correlation with disease prognosis;
3) To explore the immunogenicity of TB01 in patients with advanced colon cancer and the effects of anti-drug antibody (ADA) production on PK, efficacy and safety.