评价SG001注射液治疗恶性间皮瘤患者的有效性和安全性的开放、多中心的II期临床研究
[Translation] An open, multicenter Phase II clinical study to evaluate the efficacy and safety of SG001 injection in the treatment of patients with malignant mesothelioma
主要研究目的：根据独立评审委员会（IRC）评估的ORR评价SG001注射液在含培美曲塞化疗后进展或不能耐受化疗的恶性间皮瘤患者中的抗肿瘤疗效。 次要研究目的：
1. 研究中心评估的ORR评价SG001注射液联合甲磺酸仑伐替尼胶囊在既往应用过PD-1/ PD-L1/ PD-L2/ CTLA-4抑制剂治疗后进展的恶性间皮瘤患者中的抗肿瘤疗效。
2. 评价SG001注射液（或联合甲磺酸仑伐替尼胶囊）在所有恶性间皮瘤患者中的其他有效性指标：研究中心评估的ORR、IRC评估的缓解持续时间（DOR）、根据IRC评估的疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）、至缓解时间（TTR）。
3. 评价SG001注射液（或联合甲磺酸仑伐替尼胶囊）在所有恶性间皮瘤患者中的安全性。
4. SG001注射液在所有恶性间皮瘤患者中的药代动力学特征。
5. SG001注射液在所有恶性间皮瘤患者中的免疫原性。
6. 评价SG001注射液在所有恶性间皮瘤患者中的疗效与生物标记物的关系。
[Translation] Primary study objective: To evaluate the anti-tumor efficacy of SG001 injection in patients with malignant mesothelioma who have progressed after pemetrexed-containing chemotherapy or are intolerant to chemotherapy based on the ORR assessed by the independent review committee (IRC). Secondary study objectives:
1. To evaluate the anti-tumor efficacy of SG001 injection combined with lenvatinib mesylate capsules in patients with malignant mesothelioma who have progressed after previous treatment with PD-1/ PD-L1/ PD-L2/ CTLA-4 inhibitors based on the ORR assessed by the research center.
2. To evaluate other efficacy indicators of SG001 injection (or combined with lenvatinib mesylate capsules) in all patients with malignant mesothelioma: ORR assessed by the research center, duration of response (DOR) assessed by IRC, disease control rate (DCR) assessed by IRC, progression-free survival (PFS), overall survival (OS), and time to response (TTR).
3. To evaluate the safety of SG001 injection (or combined with lenvatinib mesylate capsules) in all patients with malignant mesothelioma.
4. Pharmacokinetic characteristics of SG001 injection in all patients with malignant mesothelioma.
5. Immunogenicity of SG001 injection in all patients with malignant mesothelioma.
6. Evaluate the relationship between the efficacy of SG001 injection and biomarkers in all patients with malignant mesothelioma.
/ Active, not recruitingPhase 2 评价SG001注射液治疗PD-L1表达阳性的复发或转移性宫颈癌患者的有效性和安全性的单臂、开放、多中心的II期临床研究
[Translation] A single-arm, open-label, multicenter Phase II clinical study to evaluate the efficacy and safety of SG001 injection in the treatment of patients with recurrent or metastatic cervical cancer with positive PD-L1 expression
一、主要研究目的： 根据独立评审委员会（IRC）评估的客观缓解率（ORR）评价SG001在至少一线含铂方案化疗失败的PD-L1表达阳性（CPS≥1）的复发或转移宫颈癌患者中的抗肿瘤疗效。
二、次要研究目的： 1. 评价SG001注射液在复发或转移性宫颈癌患者中的其他有效性指标：研究中心评估的ORR、IRC评估的缓解持续时间（DOR）、根据IRC评估的疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）、至缓解时间（TTR）。 2. 评价SG001注射液在复发或转移性宫颈癌患者中的安全性。 3. SG001注射液在复发或转移性宫颈癌患者中的药代动力学特征。 4. SG001注射液在复发或转移性宫颈癌患者中的免疫原性。
[Translation] 1. Primary study objectives: To evaluate the anti-tumor efficacy of SG001 in patients with recurrent or metastatic cervical cancer who have failed at least one line of platinum-based chemotherapy and are positive for PD-L1 expression (CPS ≥ 1), based on the objective response rate (ORR) assessed by an independent review committee (IRC).
2. Secondary study objectives: 1. To evaluate other efficacy indicators of SG001 injection in patients with recurrent or metastatic cervical cancer: ORR assessed by the research center, duration of response (DOR) assessed by IRC, disease control rate (DCR) assessed by IRC, progression-free survival (PFS), overall survival (OS), and time to response (TTR). 2. To evaluate the safety of SG001 injection in patients with recurrent or metastatic cervical cancer. 3. Pharmacokinetic characteristics of SG001 injection in patients with recurrent or metastatic cervical cancer. 4. Immunogenicity of SG001 injection in patients with recurrent or metastatic cervical cancer.
重组抗PD-1全人源单克隆抗体注射液（SG001）在晚期实体瘤受试者中的开放性、多次给药、剂量递增的Ia期临床研究
[Translation] An open-label, multiple-dose, dose-escalation Phase Ia clinical study of a recombinant anti-PD-1 fully human monoclonal antibody injection (SG001) in subjects with advanced solid tumors
评价SG001注射液多次给药在晚期实体瘤受试者中的安全性和耐受性、药代动力学特征、抗肿瘤活性、免疫原性。
[Translation] To evaluate the safety and tolerability, pharmacokinetic characteristics, antitumor activity, and immunogenicity of multiple doses of SG001 injection in subjects with advanced solid tumors.
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