Delving into the Latest Updates on Ametumumab with Synapse

This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer.

Start Date01 Jan 2023

Sponsor / Collaborator

Shanghai Serum Bio-Technology Co., Ltd.

CTR20181002 / RecruitingPhase 1/2

重组全人源抗EGFR单克隆抗体注射液治疗ras野生型晚期结直肠癌患者的安全性及有效性的Ib/II期临床试验

[Translation] Phase Ib/II clinical trial of the safety and efficacy of recombinant fully human anti-EGFR monoclonal antibody injection in the treatment of patients with ras wild-type advanced colorectal cancer

主要目的 — 研究安美木单抗联合FOLFIRI方案治疗ras野生型晚期或转移性结直肠癌患者的有效性和安全性； — 为III期给药推荐剂量。次要目的 — 评估安美木单抗的药代动力学特点； — 评估安美木单抗的免疫原性；探索性目的 — 评估潜在的药效学生物学标记物； — 评估潜在的预测性生物学标记物；

[Translation]

Primary Objectives - To investigate the efficacy and safety of amikacin combined with FOLFIRI in patients with ras wild-type advanced or metastatic colorectal cancer; - To recommend a dose for Phase III administration. Secondary Objectives - To evaluate the pharmacokinetic characteristics of amikacin; - To evaluate the immunogenicity of amikacin; Exploratory Objectives - To evaluate potential pharmacodynamic biomarkers; - To evaluate potential predictive biomarkers;

Start Date06 Aug 2018

Sponsor / Collaborator

Shanghai Serum Bio-Technology Co., Ltd.

[+1]

CTR20170343 / CompletedPhase 1

重组全人源抗EGFR单克隆抗体注射液治疗晚期实体瘤患者的耐受性及药代动力学的Ia期临床试验

[Translation] Phase Ia clinical trial of tolerability and pharmacokinetics of recombinant fully human anti-EGFR monoclonal antibody injection in patients with advanced solid tumors

主要目的：研究安美木单抗在晚期实体瘤患者中单剂量递增给药，以及多次连续给药安全性和药代动力学特点，确定DLT及MTD，为后期临床研究推荐合理的给药方案。次要目的：评估安美木单抗的免疫原性；初步探索安美木单抗的有效性；初步探索基因表达与疗效的相关性。

[Translation]

The main purpose is to study the safety and pharmacokinetic characteristics of single-dose escalation and multiple continuous administration of Amitumab in patients with advanced solid tumors, determine the DLT and MTD, and recommend a reasonable dosing regimen for later clinical studies. Secondary objectives are to evaluate the immunogenicity of Amitumab; preliminarily explore the effectiveness of Amitumab; and preliminarily explore the correlation between gene expression and efficacy.

Start Date25 Apr 2017

Sponsor / Collaborator

Shanghai Serum Bio-Technology Co., Ltd.

[+1]

100 Clinical Results associated with Ametumumab

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100 Translational Medicine associated with Ametumumab

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100 Patents (Medical) associated with Ametumumab

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Literatures (Medical) associated with Ametumumab

01 Jan 2023·Therapeutic Advances in Medical Oncology

A phase Ia dose-escalation trial of Ametumumab (a fully human monoclonal antibody against epidermal growth factor receptor) in patients with advanced solid malignancies

Article

Author: Jin, Wei ; Zhu, Kongli ; Zheng, Yu ; Xue, Yanan ; Zhao, Xianfeng ; Fang, Yong ; Pan, Hongming ; Wang, Wei ; Xu, Rong ; Li, Da ; Lou, Haizhou ; Han, Jin ; Pan, Hong ; Han, Weidong ; Pan, Qin

Background: Epidermal growth factor receptor (EGFR) is a well-known target for cancer treatment. However, the authorized anti-EGFR monoclonal antibodies generally cause several toxic effects, especially severe cutaneous toxicities as well as infusion reactions, and the clinical indications are limited. Here we developed Ametumumab, a fully human recombinant anti-EGFR monoclonal antibody. Objectives: To assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of Ametumumab. Design: A first-in-human phase Ia dose escalation study of Ametumumab in patients with advanced solid malignancies. Methods: An open-label, first-in-human dose escalation study was done in 22 patients with advanced malignancies who received six ascending dosages ranging from 75 to 750 mg/m2. Following a single dosage and a 28-day dose-limiting toxicity (DLT) monitoring period, patients were given repeated doses weekly. Blood samples were taken to determine the PK parameters of Ametumumab and anti-drug antibody concentrations. Every 8 weeks, radiographic tumor evaluations were conducted. Results: In this trial, no DLT was observed, and the maximum tolerated dose was not reached at doses up to 750 mg/m2. There were no severe adverse events but mild and moderate adverse effects, such as headache, proteinuria, and rash. Single-dose PK results demonstrated a straightforward linear relationship with dosage escalation. The medication concentrations accumulated and attained steady-state after four rounds of injections. It was calculated that 10 patients with disease control would be observed in the 22 evaluable patients. The disease control rate was 45.5%. Conclusion: The Ametumumab was well tolerated and safe in patients with advanced solid malignancies, exhibiting minimal immunogenicity, a long half-life, high levels of drug exposure in the blood, and preliminary effectiveness. Registration: The trial was registered with CTR20170343 on 10 April 2017, The China Center for Drug Evaluation.

100 Deals associated with Ametumumab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 3	CN	Shanghai Serum Bio-Technology Co., Ltd.	25 Apr 2017
RAS Wild Type Colorectal Cancer	Phase 2	CN	Shanghai Serum Bio-Technology Co., Ltd.	08 Jan 2020
RAS Wild Type Colorectal Cancer	Phase 2	CN	Chinese PLA Academy of Military Medical Sciences	08 Jan 2020
Advanced Malignant Solid Neoplasm	Discovery	CN	Chinese PLA Academy of Military Medical Sciences	25 Apr 2017
Colorectal Cancer	Discovery	CN	Academy of Military Medical Sciences	30 Jul 2015