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MechanismRANKL inhibitors |
Active Org.- |
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Active Indication- |
Inactive Indication- |
Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
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MechanismEGFR antagonists |
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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
西妥昔单抗注射液和爱必妥分别联合mFOLFOX6一线治疗RAS/BRAF野生型转移性结直肠癌患者的有效性、安全性及免疫原性的临床试验
[Translation] Clinical trial of efficacy, safety and immunogenicity of cetuximab injection and erbitux combined with mFOLFOX6 in first-line treatment of patients with RAS/BRAF wild-type metastatic colorectal cancer
主要目的 比较西妥昔单抗注射液与爱必妥®分别联合mFOLFOX6在治疗RAS/BRAF野生型转移性结直肠癌患者的疗效,以证明其临床等效性。 次要目的 比较西妥昔单抗注射液与爱必妥®分别联合mFOLFOX6在治疗RAS/BRAF野生型转移性结直肠癌患者的 (1)安全性及免疫原性; (2)体内的药代特征;初步探索抗EGFR单抗疗效的其他肿瘤标志物以及抗EGFR单抗继发耐药的基因变异。
[Translation] Main objective To compare the efficacy of cetuximab injection and Erbitux® combined with mFOLFOX6 in the treatment of patients with RAS/BRAF wild-type metastatic colorectal cancer to prove their clinical equivalence. Secondary Objective To compare the (1) safety and immunogenicity of cetuximab injection and Erbitux® combined with mFOLFOX6 in the treatment of patients with RAS/BRAF wild-type metastatic colorectal cancer; (2) pharmacokinetics in vivo Features; preliminary exploration of other tumor markers for the efficacy of anti-EGFR monoclonal antibodies and gene variants of secondary resistance to anti-EGFR monoclonal antibodies.
比较性观察西妥昔单抗注射液与爱必妥在健康志愿者中的安全性、药代动力学和 免疫原性特征
[Translation] Comparative observation of safety, pharmacokinetics and immunogenicity of cetuximab injection and Erbitux in healthy volunteers
主要研究目的:比较性评估西妥昔单抗注射液(APZ001)与爱必妥®在健康志愿者中的安全性和药代动力学特征。 次要研究目的:比较性观察西妥昔单抗注射液(APZ001)与爱必妥®在健康志愿者体内的免疫原性特征。
[Translation] MAIN STUDY OBJECTIVE: To comparatively evaluate the safety and pharmacokinetics of cetuximab injection (APZ001) and Erbitux® in healthy volunteers. Secondary research objectives: To compare the immunogenicity characteristics of cetuximab injection (APZ001) and Erbitux® in healthy volunteers.
100 Clinical Results associated with AMPO Biotechnology, Inc.
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100 Translational Medicine associated with AMPO Biotechnology, Inc.