[Translation] A non-randomized, open-label, first-in-human Phase I clinical study to evaluate the safety and tolerability, pharmacokinetics and preliminary efficacy of CBP-1018 for injection in patients with advanced malignant solid tumors
主要研究目的:
1. 评估CBP-1018在晚期恶性实体瘤患者中的安全性和耐受性;
2. Ⅰa期:确定CBP-1018在晚期恶性实体瘤患者的最大耐受剂量(MTD)和Ⅱ期推荐剂量(RP2D);
3. Ⅰb期:评估CBP-1018在各种晚期恶性实体瘤患者的客观反应率(ORR)。
次要研究目的:
1. Ⅰa期:评估CBP-1018在晚期恶性实体瘤患者的抗肿瘤活性;
2. Ⅰb期:评估CBP-1018在各种晚期恶性实体瘤患者除ORR外的其他疗效指标;
3. 评估CBP-1018和MMAE在晚期恶性实体瘤患者中的药代动力学(PK)特征;
4. 评估在晚期恶性实体瘤患者中的免疫原性。
探索性目的:
1. 探索与CBP-1018疗效相关的生物标志物;
2. 探索mCRPC神经内分泌或小细胞转化与CBP-1018疗效的关系;
3. 尽可能获得CBP-1018在人体内的药物代谢产物信息。
[Translation] Main research purposes:
1. To evaluate the safety and tolerability of CBP-1018 in patients with advanced malignant solid tumors;
2. Phase Ia: To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of CBP-1018 in patients with advanced malignant solid tumors;
3. Phase Ib: To evaluate the objective response rate (ORR) of CBP-1018 in patients with various advanced malignant solid tumors.
Secondary research purposes:
1. Phase Ia: To evaluate the antitumor activity of CBP-1018 in patients with advanced malignant solid tumors;
2. Phase Ib: To evaluate other efficacy indicators of CBP-1018 in addition to ORR in patients with various advanced malignant solid tumors;
3. To evaluate the pharmacokinetic (PK) characteristics of CBP-1018 and MMAE in patients with advanced malignant solid tumors;
4. Assess immunogenicity in patients with advanced malignant solid tumors.
Exploratory Purpose:
1. Explore biomarkers related to the efficacy of CBP-1018;
2. To explore the relationship between mCRPC neuroendocrine or small cell transformation and the efficacy of CBP-1018;
3. Obtain information on drug metabolites of CBP-1018 in humans as much as possible.