评价重组人源化抗CD47/PD-1双功能抗体HX009注射液在中国复发/难治性淋巴瘤患者中开展的多中心、开放、单臂的Ⅰ/Ⅱ期临床研究
[Translation] A multicenter, open-label, single-arm Phase I/II clinical study evaluating the recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in Chinese patients with relapsed/refractory lymphoma
I 期剂量递增阶段：
主要目的：
1. 观察重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤患者的安全性和耐受性；
2. 确定Ⅱ期临床推荐剂量（RP2D）和最大耐受剂量（MTD）。
Ⅱ期疗效探索及确证阶段：
主要目的：
1. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤患者的疗效。
次要目的：
1. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤的安全性；
2. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤的药代动力学特征；
3. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤的免疫原性。
[Translation] Phase I dose escalation phase:
Main purpose:
1. To observe the safety and tolerability of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of patients with relapsed/refractory lymphoma;
2. To determine the recommended dose (RP2D) and maximum tolerated dose (MTD) for Phase II clinical trials.
Phase II efficacy exploration and confirmation phase:
Main purpose:
1. To evaluate the efficacy of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of patients with relapsed/refractory lymphoma.
Secondary objectives:
1. To evaluate the safety of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of relapsed/refractory lymphoma;
2. To evaluate the pharmacokinetic characteristics of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of relapsed/refractory lymphoma;
3. To evaluate the immunogenicity of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of relapsed/refractory lymphoma.
重组人源化抗CD47/PD-1双功能抗体HX009注射液治疗晚期实体瘤的多中心II期临床研究
[Translation] A multicenter phase II clinical study of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of advanced solid tumors
主要目的： 根据独立评审委员会（IRC）评估的客观缓解率（ORR）评估 HX009 注射液的疗效。
次要目的： 根据研究者评估的 ORR 评估 HX009 注射液在晚期实体瘤患者的疗效； 评价 HX009 注射液在晚期实体瘤患者的缓解持续时间（DOR）； 评价 HX009 注射液在晚期实体瘤患者的疾病控制率（DCR）； 评价 HX009 注射液在晚期实体瘤患者的无进展生存期（PFS）； 评价 HX009 注射液在晚期实体瘤患者的总生存期（OS）； 评估 HX009 注射液在晚期实体瘤患者的安全性和耐受性； 评估 HX009 注射液的药代动力学（PK）； 评价 HX009 注射液输注后抗药抗体（ADA）和中和抗体（Nab）； 评价 HX009 注射液输注后外周血 T 细胞表面受体占有率（RO）。
探索性目的： 探索 HX009 注射液疗效相关的生物标志物（包括 PD-L1 表达、CD47 表达和外周血 ct DNA）， 以及与不良事件之间的关系。
[Translation] Primary objective: To evaluate the efficacy of HX009 injection according to the objective response rate (ORR) assessed by an independent review committee (IRC).
Secondary objectives: To evaluate the efficacy of HX009 injection in patients with advanced solid tumors according to the ORR assessed by the investigator; To evaluate the duration of response (DOR) of HX009 injection in patients with advanced solid tumors; To evaluate the disease control rate (DCR) of HX009 injection in patients with advanced solid tumors; To evaluate the progression-free survival (PFS) of HX009 injection in patients with advanced solid tumors; To evaluate the overall survival (OS) of HX009 injection in patients with advanced solid tumors; To evaluate the safety and tolerability of HX009 injection in patients with advanced solid tumors; To evaluate the pharmacokinetics (PK) of HX009 injection; To evaluate the anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after infusion of HX009 injection; To evaluate the peripheral blood T cell surface receptor occupancy (RO) after infusion of HX009 injection.
Exploratory purpose: To explore the biomarkers related to the efficacy of HX009 injection (including PD-L1 expression, CD47 expression and peripheral blood ct DNA), and their relationship with adverse events.
HX301单乳酸盐胶囊在晚期实体瘤患者中的耐受性及 药代动力学Ⅰ期临床研究
[Translation] Phase I clinical study on the tolerability and pharmacokinetics of HX301 monolactate capsules in patients with advanced solid tumors
主要目的： 评估HX301单乳酸盐胶囊在晚期实体瘤中的耐受性和安全性。 次要目的： 1.观察HX301单乳酸盐胶囊在实体瘤患者中的药代动力学（Pharmacokinetics，PK）特征； 2.初步评价HX301单乳酸盐胶囊治疗晚期实体瘤的有效性（包括客观缓解率ORR、无进展生存期PFS、缓解持续时间DOR、疾病控制率DCR等指标）。
[Translation] Primary objective: To evaluate the tolerability and safety of HX301 monolactate capsules in patients with advanced solid tumors. Secondary objectives: 1. To observe the pharmacokinetic (PK) characteristics of HX301 monolactate capsules in patients with solid tumors; 2. To preliminarily evaluate the effectiveness of HX301 monolactate capsules in the treatment of advanced solid tumors (including objective response rate ORR, progression-free survival PFS, duration of response DOR, disease control rate DCR and other indicators).
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