[Translation] A multicenter, open-label, evaluation of the safety, tolerability and pharmacokinetics of weekly CBP-1008 weekly regimens for injection in patients with advanced malignant solid tumors positive for FOLR1 and/or TRPV6 expression and expanded in selected indications Phase Ia, Ib studies
主要目的:
1. 评估DLT并确定MTD;
2. 确定RP2D;
3. 评估CBP-1008的安全性、耐受性和免疫原性。
次要目的:
1. 评估CBP-1008在晚期恶性实体瘤患者中的抗肿瘤活性;
2. 确定单次剂量下和多次剂量下CBP-1008及其主要代谢产物的PK特征。
探索性目的:
1. 识别CBP-1008疗效的潜在预测性生物标志物。
[Translation] main purpose:
1. Assess the DLT and determine the MTD;
2. Determine RP2D;
3. To evaluate the safety, tolerability and immunogenicity of CBP-1008.
Secondary purpose:
1. To evaluate the antitumor activity of CBP-1008 in patients with advanced malignant solid tumors;
2. Determine the PK profile of CBP-1008 and its major metabolites at single and multiple doses.
Exploratory Purpose:
1. Identify potential predictive biomarkers of CBP-1008 efficacy.