[Translation] An open-label, dose-escalation Phase I study evaluating the safety, tolerability, and preliminary efficacy of a single dose of E10B in patients with advanced castration-resistant prostate cancer
主要目的:
评价重组人γ-干扰素腺病毒注射液在晚期去势抵抗性前列腺癌患者中单次给药剂量递增的安全性和耐受性。
次要目的:
1) 评价重组人γ-干扰素腺病毒注射液在晚期去势抵抗性前列腺癌患者中单次给药的药代动力学/药效动力学(PK/PD)特征。
2) 评价重组人γ-干扰素腺病毒注射液在晚期去势抵抗性前列腺癌患者中单次给药的初步疗效。
3) 评价重组人γ-干扰素腺病毒注射液在晚期去势抵抗性前列腺癌患者中单次给药的免疫原性特征。
[Translation] Primary objective:
To evaluate the safety and tolerability of a single dose escalation of recombinant human interferon-γ adenovirus injection in patients with advanced castration-resistant prostate cancer.
Secondary objectives:
1) To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of recombinant human interferon-γ adenovirus injection in patients with advanced castration-resistant prostate cancer.
2) To evaluate the preliminary efficacy of a single dose of recombinant human interferon-γ adenovirus injection in patients with advanced castration-resistant prostate cancer.
3) To evaluate the immunogenicity characteristics of a single dose of recombinant human interferon-γ adenovirus injection in patients with advanced castration-resistant prostate cancer.