[Translation] A phase Ib/III study comparing sevicietamab in combination with trifluuridine/tipiracil tablets (FTD/TPI) versus placebo in combination with trifluuridine/tipiracil tablets in refractory metastatic colorectal cancer (currently only phase Ib studies are underway).
Ib期主要目的:评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片的安全性和耐受性。 Ib期次要目的:1. 评价苏维西塔单抗的药代动力学(PK)和免疫原性;2. 评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片在难治性转移性结直肠癌受试者中的初步抗肿瘤活性。 III期主要目的:评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片在难治性转移性结直肠癌受试者中的有效性。 III期次要目的:1. 进一步评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片在难治性转移性结直肠癌受试者中的有效性;2. 评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片在难治性转移性结直肠癌受试者中的安全性特征 3. 评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片对难治性转移性结直肠癌受试者生活质量的影响;4. 评价苏维西塔单抗联合曲氟尿苷替匹嘧啶片的PK和免疫原性。
III期探索性目的:探索PK、药效学、安全性和临床有效性之间的关系。
[Translation] Phase Ib primary objective: To evaluate the safety and tolerability of suvicidumab in combination with trifluuridine ticipiramycin tablets. Phase Ib secondary objectives: 1. To evaluate the pharmacokinetics (PK) and immunogenicity of suvicidumab; 2. To evaluate the preliminary antitumor activity of suvicidumab in combination with trifluuridine ticipiramycin tablets in patients with refractory metastatic colorectal cancer. Phase III primary objective: To evaluate the efficacy of suvicidumab in combination with trifluuridine ticipiramycin tablets in patients with refractory metastatic colorectal cancer. Phase III Secondary Objectives: 1. To further evaluate the efficacy of suvicetumab in combination with trifluuridine tepiraprazine in patients with refractory metastatic colorectal cancer; 2. To evaluate the safety profile of suvicetumab in combination with trifluuridine tepiraprazine in patients with refractory metastatic colorectal cancer; 3. To evaluate the impact of suvicetumab in combination with trifluuridine tepiraprazine on the quality of life of patients with refractory metastatic colorectal cancer; 4. To evaluate the pharmacokinetics (PK) and immunogenicity of suvicetumab in combination with trifluuridine tepiraprazine.
Phase III Exploratory Objectives: To explore the relationship between PK, pharmacodynamics, safety, and clinical efficacy.