A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer

This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.

Start Date24 Apr 2017

Sponsor / Collaborator

AbGenomics B.V Taiwan Branch

100 Clinical Results associated with AbGn-107

100 Translational Medicine associated with AbGn-107

100 Patents (Medical) associated with AbGn-107

Literatures (Medical) associated with AbGn-107

01 Apr 2024·Investigational New Drugs

A multicenter phase Ia study of AbGn-107, a novel antibody–drug conjugate, in patients with advanced gastrointestinal cancer

Article

Author: Clark, Jeffrey W ; Langecker, Peter ; Schlechter, Benjamin L ; Bekaii-Saab, Tanios ; Coveler, Andrew L ; Wolpin, Brian M ; Lin, Yu-Chin ; Ko, Andrew H ; Bockorny, Bruno ; Lin, Shih-Yao ; Chiang, Evelyn ; Bai, Li-Yuan

AbGn-107 is an antibody-drug conjugate directed against AG-7 antigen, a Lewis A-like glycol-epitope expressed in a variety of gastrointestinal (GI) malignancies. Based on promising antitumor activity of AbGn-107 in both in vitro and in vivo preclinical studies, we performed a GI cancer-specific Phase I trial. Standard 3 + 3 dose escalation was used evaluating intravenous doses ranging from 0.1 mg/kg every 4 weeks to 1.0 mg/kg every 2 weeks. Key eligibility included chemo-refractory locally advanced, recurrent, or metastatic gastric, colorectal, pancreatic, or biliary cancer, with ECOG PS 0-1; positive AG-7 expression was not required during dose escalation phase. Patients were treated until disease progression or unacceptable toxicity, with tumor assessments every 8 weeks. Primary objectives included safety and determination of maximum tolerated dose; secondary objectives included efficacy defined by objective response rate. Thirty-nine patients were enrolled across seven dose levels during dose escalation phase. Based on safety profile and pharmacokinetic data, 1.0 mg/kg Q2W was selected as the dose schedule for cohort expansion phase, in which an additional seven patients were enrolled. Median number of lines of prior therapy was 3 (range 1-7). AbGn-107 was generally well-tolerated, with infections, cytopenias, hyponatremia, fatigue, abdominal pain, and diarrhea representing the most common grade 3 or higher treatment-emergent adverse events. One subject achieved a partial response, while 18 (46.2%) achieved a best response of stable disease. Disease control lasting > 6 months was observed in 6 subjects (13.0%), including 4 of 15 (26.7%) treated at the highest dose level. AbGn-107 showed a reasonable safety profile and modest clinical activity in this highly pretreated patient population. Further evaluation is required to assess the clinical validity of AG-7 as a suitable antigen for therapeutic targeting. Clinical Trial information: NCT02908451.

100 Deals associated with AbGn-107

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Indication	Highest Phase	Country/Location	Organization	Date
Biliary Tract Neoplasms	Phase 1	Taiwan Province	AbGenomics B.V Taiwan Branch	24 Apr 2017
Biliary Tract Neoplasms	Phase 1	United States	AbGenomics B.V Taiwan Branch	24 Apr 2017
Biliary Tract Neoplasms	Phase 1	Taiwan Province	AbGenomics B.V Taiwan Branch	24 Apr 2017
Biliary Tract Neoplasms	Phase 1	United States	AbGenomics B.V Taiwan Branch	24 Apr 2017
Pancreatic Cancer	Phase 1	Taiwan Province	AbGenomics International, Inc.	22 Apr 2017
Pancreatic Cancer	Phase 1	Taiwan Province	AbGenomics International, Inc.	22 Apr 2017
Colorectal Cancer	Phase 1	Taiwan Province	AbGenomics International, Inc.	10 Apr 2017
Colorectal Cancer	Phase 1	Taiwan Province	AbGenomics International, Inc.	10 Apr 2017
Stomach Cancer	Phase 1	Taiwan Province	AbGenomics International, Inc.	08 Apr 2017
Stomach Cancer	Phase 1	Taiwan Province	AbGenomics International, Inc.	08 Apr 2017

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