[Translation] A Phase IIa clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of recombinant acylated glucagon-like peptide-2 analogue (FT1) for injection in preventing diarrhea in HER2-positive breast cancer patients receiving pyrotinib-containing combination therapy.
要目的:
评估FT1在接受含吡咯替尼联合方案治疗的人表皮生长因子受体2(HER2)阳性乳腺癌患者中的安全性和耐受性;
评估FT1在接受含吡咯替尼联合方案治疗的HER2阳性乳腺癌患者中预防腹泻的有效性。
次要目的:
评估FT1在接受含吡咯替尼联合方案治疗的HER2阳性乳腺癌患者中的群体药代动力学特征;
评估FT1在接受含吡咯替尼联合方案治疗的HER2阳性乳腺癌患者中的药效学(PD)特征;
评估FT1在接受含吡咯替尼联合方案治疗的HER2阳性乳腺癌患者中的免疫原性。
探索性目的:
评估FT1对接受含吡咯替尼联合方案治疗的HER2阳性乳腺癌患者肠道菌群的影响。
评估FT1对吡咯替尼在HER2阳性乳腺癌患者中PK特征的影响。
[Translation] Primary Objectives:
To evaluate the safety and tolerability of FT1 in patients with HER2-positive breast cancer treated with a pyrotinib-containing combination regimen;
To evaluate the efficacy of FT1 in preventing diarrhea in patients with HER2-positive breast cancer treated with a pyrotinib-containing combination regimen.
Secondary Objectives:
To evaluate the population pharmacokinetic characteristics of FT1 in patients with HER2-positive breast cancer treated with a pyrotinib-containing combination regimen;
To evaluate the pharmacodynamic (PD) characteristics of FT1 in patients with HER2-positive breast cancer treated with a pyrotinib-containing combination regimen;
To evaluate the immunogenicity of FT1 in patients with HER2-positive breast cancer treated with a pyrotinib-containing combination regimen.
Exploratory Objectives:
To evaluate the effect of FT1 on the gut microbiota in patients with HER2-positive breast cancer treated with a pyrotinib-containing combination regimen.
To evaluate the effect of FT1 on the PK characteristics of pyrotinib in patients with HER2-positive breast cancer.