MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.

Start Date21 Apr 2021

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

CTR20202436 / RecruitingPhase 1/2

评价重组人源化单克隆抗体MIL93 注射液治疗局部晚期或转移性实体瘤的耐受性、安全性、药代动力学和初步疗效的I/Ⅱ期临床研究

[Translation] A phase I/II clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of recombinant humanized monoclonal antibody MIL93 injection in the treatment of locally advanced or metastatic solid tumors

第一阶段：评价 MIL93 单药在不可切除的局部晚期或转移性实体瘤患者中的耐受性和安全性，并确定剂量限制性毒性（DLT）和最大耐受剂量（MTD）。第二阶段：评价MIL93 联合化疗在不可切除的局部晚期或转移性胃和胃食管结合部腺癌、胰腺癌、胆道癌患者中的客观缓解率（ORR）。第三阶段：评价MIL93 联合化疗或PD-1 单抗+/-化疗在不可切除的局部晚期或转移性胃和胃食管结合部腺癌患者中的客观缓解率（ORR）。

[Translation]

Phase I: Evaluate the tolerability and safety of MIL93 monotherapy in patients with unresectable locally advanced or metastatic solid tumors, and determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD). Phase II: Evaluate the objective response rate (ORR) of MIL93 combined with chemotherapy in patients with unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, pancreatic cancer, and biliary tract cancer. Phase III: Evaluate the objective response rate (ORR) of MIL93 combined with chemotherapy or PD-1 monoclonal antibody +/- chemotherapy in patients with unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.

Start Date21 Apr 2021

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

100 Clinical Results associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

100 Translational Medicine associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

100 Patents (Medical) associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

Literatures (Medical) associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

03 Apr 2017·Expert Opinion on Drug SafetyQ3 · MEDICINE

Safety of tocilizumab in the treatment of juvenile idiopathic arthritis

Q3 · MEDICINE

Review

Author: Machado, Sandra Helena ; Xavier, Ricardo Machado

INTRODUCTIONTocilizumab (TCZ) is a recombinant humanized monoclonal antibody and IL-6 receptor antagonist, currently approved for the treatment of systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) in children aged 2 years or older refractory to conventional treatment. The most common adverse events in patients treated with TCZ were infections, especially in the respiratory tract. The most frequent laboratory abnormalities were altered liver function, neutropenia and elevated cholesterol levels. Areas covered: The safety of TCZ in the treatment of children with JIA was determined based on a review of published clinical trials, including two multicenter studies of patients with sJIA and pJIA (the TENDER and CHERISH trials, respectively). The frequency of adverse events (AEs), serious adverse events (SAEs) and deaths reported in these studies was analyzed and discussed. Expert opinion: TCZ was effective and well tolerated in the treatment of severe forms of sJIA and pJIA, and can be considered a treatment of choice for these conditions. The risk of infections and laboratory abnormalities, such as neutropenia, should be constantly monitored. There is still a need for comparative studies of the risks and benefits of biological agents in patients with refractory JIA.

01 Aug 2014·International ImmunopharmacologyQ2 · MEDICINE

Treatment with the C5a receptor/CD88 antagonist PMX205 reduces inflammation in a murine model of allergic asthma

Q2 · MEDICINE

Article

Author: Staab, Elizabeth B ; Sanderson, Sam D ; Wells, Sandra M ; Poole, Jill A

Allergic asthma is a chronic inflammatory airway disease arising from an aberrant immune response following exposure to environmental stimuli in genetically susceptible persons. The complement component 5 (C5)/C5a Receptor (C5aR/CD88) signaling pathway has been implicated in both experimental allergic asthma and human asthmatic disease. Targeting the C5a/C5aR signaling pathway in rodent models has been shown to either enhance or reduce allergic asthma consequences. Treatment with a recombinant humanized monoclonal antibody directed against C5 has shown unclear results in patients with asthma. The objective of this proof-of-concept animal study was to determine whether the low molecular weight C5aR peptidomimetic antagonist, PMX205, would reduce experimental allergic asthma consequences in mice. PMX205 or vehicle control was administered subcutaneously to BALB/c mice prior to and during standard ovalbumin (OVA) allergen sensitization and aerosolized challenge phases. PMX205 substantially reduced OVA-induced total cell (60%), neutrophil (66%) and eosinophil (65%) influxes in lavage fluid sampling. There were also significant reductions in OVA-induced lavage fluid IL-13 protein and lung Th2 cytokine gene expression with PMX205 administration. PMX205 treatment also diminished OVA-induced lung parenchyma cellular infiltration. PMX205 administration did not reduce OVA-induced serum IgE levels or epithelial mucous/goblet cell generation. There was no evidence of toxicity observed with PMX205 treatment in saline or OVA-challenged animals. These data provide evidence that pharmacologic blockade of C5aR by a low molecular weight antagonist (PMX205) reduces airway inflammatory cell and cytokine responses in experimental allergic asthma, and suggests that PMX205 might represent a novel therapeutic agent for reducing asthmatic outcomes.

100 Deals associated with Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
CLDN18.2 positive Gastrooesophageal junction cancer	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	-
CLDN18.2 positive Pancreatic Cancer	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	-
CLDN18.2 positive Stomach Cancer	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	-
Metastatic Solid Tumor	Phase 1	CN	Beijing Mabworks Biotech Co., Ltd.	21 Apr 2021
CLDN18.2 Positive Gastrointestinal Neoplasms	IND Approval	CN	Beijing Mabworks Biotech Co., Ltd.	29 Dec 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04671875 (ASCO_GI2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	30	MIL93	(omvfcoaydq) = rpoppeefrr squaivxvvs (ddilfsoqbe ) View more	Positive	24 Jan 2023
NCT04671875 (MIL93-CT101, ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	13	MIL93	(eyfxjxicrk) = yvivbcunlh ilmsyoythv (rhqvpnqkwe ) View more	Positive	02 Jun 2022

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Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

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