[Translation] Tolerability, pharmacokinetics and preliminary efficacy exploration of BM201 injection combined with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard treatment or cannot receive standard treatment clinical research
主要目的:
1)评价BM201注射液联合放射治疗在晚期实体瘤患者中的剂量限制性毒性(DLT),探索最高给药剂量或最大耐受剂量(MTD);
2)评价BM201注射液联合放射治疗在晚期实体瘤患者中的安全性;
3)探索BM201注射液联合放射治疗在晚期实体瘤患者中的人体药代动力学特征。
次要目的:
1)初步评价BM201注射液联合放射治疗在晚期实体瘤患者中的抗肿瘤活性;
2)探索与疗效、安全性、作用机制相关的细胞因子、肿瘤标志物较基线的变化。
[Translation] main purpose:
1) Evaluate the dose-limiting toxicity (DLT) of BM201 injection combined with radiation therapy in patients with advanced solid tumors, and explore the highest administered dose or maximum tolerated dose (MTD);
2) To evaluate the safety of BM201 injection combined with radiotherapy in patients with advanced solid tumors;
3) To explore the human pharmacokinetic characteristics of BM201 injection combined with radiotherapy in patients with advanced solid tumors.
Secondary purpose:
1) Preliminary evaluation of the anti-tumor activity of BM201 injection combined with radiotherapy in patients with advanced solid tumors;
2) Explore changes in cytokines and tumor markers related to efficacy, safety, and mechanism of action compared with baseline.