[Translation] A Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BY101298 alone or in combination with radiotherapy in patients with malignant solid tumors
Ia期:
主要目的:评价BY101298在晚期恶性实体瘤患者中的安全性、耐受性。
次要目的:评价BY101298在晚期恶性实体瘤患者中的药代动力学(PK)特征; 初步探索BY101298在晚期恶性实体瘤患者中的有效性。
Ib期:
主要目的:评价BY101298联合放疗在恶性实体瘤患者中的安全性、耐受性。
次要目的:初步探索BY101298联合放疗在恶性实体瘤患者中的有效性; 评价BY101298联合放疗在恶性实体瘤患者中的药代动力学(PK)特征。
[Translation] Phase Ia:
Primary purpose: To evaluate the safety and tolerability of BY101298 in patients with advanced malignant solid tumors.
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of BY101298 in patients with advanced malignant solid tumors; To preliminarily explore the effectiveness of BY101298 in patients with advanced malignant solid tumors.
Phase Ib:
Primary purpose: To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with malignant solid tumors.
Secondary purpose: To preliminarily explore the effectiveness of BY101298 combined with radiotherapy in patients with malignant solid tumors; To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with malignant solid tumors.