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: Zhu, Kongli ; Jin, Wei ; Zheng, Yu ; Xue, Yanan ; Zhao, Xianfeng ; Pan, Hongming ; Fang, Yong ; 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
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	Phase 1	CN	Chinese PLA Academy of Military Medical Sciences	25 Apr 2017
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Serum Bio-Technology Co., Ltd.	25 Apr 2017
Colorectal Cancer	Phase 1	CN	Academy of Military Medical Sciences	30 Jul 2015