[Translation] Phase I clinical trial to evaluate the tolerability, pharmacokinetics and preliminary efficacy of TQB2210 injection in subjects with advanced malignant tumors
1.主要目的: ·评估TQB2210注射液在晚期恶性肿瘤受试者中的耐受性; ·评估TQB2210注射液单药或联合化疗在FGFR2b过表达的晚期胃或胃食管交界部癌等FGFR2b过表达的晚期恶性肿瘤中的有效性和II期推荐剂量(RP2D)
2.次要目的: ·评价TQB2210注射液在晚期恶性肿瘤受试者的安全性;评估TQB2210注射液在晚期恶性肿瘤受试者中的有效性; ·TQB2210注射液在晚期恶性肿瘤受试者的药代动力学特征;TQB2210注射液的免疫原性特征。
3.探索性目的: ·评价生物标志物FGFR2b表达情况与疗效的关系。
[Translation] 1. Primary objectives: · To evaluate the tolerability of TQB2210 injection in subjects with advanced malignant tumors; · To evaluate the efficacy and phase II recommended dose (RP2D) of TQB2210 injection alone or in combination with chemotherapy in advanced malignant tumors with FGFR2b overexpression, such as advanced gastric or gastroesophageal junction cancer
2. Secondary objectives: · To evaluate the safety of TQB2210 injection in subjects with advanced malignant tumors; To evaluate the efficacy of TQB2210 injection in subjects with advanced malignant tumors; · Pharmacokinetic characteristics of TQB2210 injection in subjects with advanced malignant tumors; Immunogenicity characteristics of TQB2210 injection.
3. Exploratory objectives: · To evaluate the relationship between the expression of the biomarker FGFR2b and the efficacy.