A Phase 1 A/B Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AbGn-7 Therapy Alone and in Combination With the FOLFOX7 Treatment Regimen in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability profile including the dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.

Start Date01 Nov 2011

Sponsor / Collaborator

AbGenomics B.V Taiwan Branch

100 Clinical Results associated with AbGn-7

100 Translational Medicine associated with AbGn-7

100 Patents (Medical) associated with AbGn-7

Literatures (Medical) associated with AbGn-7

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 ; Wolpin, Brian M ; Coveler, Andrew L ; 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.

14 Feb 2023·Analytical Chemistry

Homoadamantane-Fused Tetrahydroquinoxaline as a Robust Electron-Donating Unit for High-Performance Asymmetric NIR Rhodamine Development

Article

Author: Chen, Zhipeng ; Sheng, Jiarong ; Song, Xiangzhi ; Xiao, Qi ; Yang, Lei ; Xu, Wenju ; Xu, Feifei ; Chen, Wenqiang

Rhodamines have emerged as a useful class of dye for bioimaging. However, intrinsic issues such as short emission wavelengths and small Stokes shifts limit their widespread applications in living systems. By taking advantage of the homoadamantane-fused tetrahydroquinoxaline (HFT) moiety as an electron donor, we developed a new class of asymmetric NIR rhodamine dyes, NNR1-7. These new dyes retained ideal photophysical properties from the classical rhodamine scaffold and showed large Stokes shifts (>80 nm) with improved chemo/photostability. We found that NNR1-7 specifically target cellular mitochondria with superior photobleaching resistance and improved tolerance for cell fixation compared to commercial mitochondria trackers. Based on NNR4, a novel NIR pH sensor (NNR4M) was also constructed and successfully applied for real-time monitoring of variations in lysosomal pH. We envision this design strategy would find broad applications in the development of highly stable NIR dyes with a large Stokes shift.

01 Jul 2021·Comparative Biochemistry and Physiology Part C: Toxicology & PharmacologyQ3 · ENVIRONMENTAL SCIENCE & ECOLOGY

Isohemigossypolone: Antiophidic properties of a naphthoquinone isolated from Pachira aquatica Aubl.

Q3 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Ferreira, Glaucio Monteiro ; Mendes, Mirian Machado ; Gonçalves, Ricardo Lemes ; Hirata, Mario Hiroyuki ; Brandeburgo, Maria Inês Homsi ; Gomes, Mario Sergio Rocha ; da Silva, Roosevelt Alves ; de Paula, Vanderlúcia Fonseca ; Dos Santos, Benedito Matheus ; Santos Júnior, Célio Dias ; Vieira, Sâmela Alves Pereira Batista

We investigated the antiophidic properties of isohemigossypolone (ISO), a naphthoquinone isolated from the outer bark of the Pachira aquatic Aubl. The inhibition of phospholipase A₂, coagulant, fibrinogenolytic, hemorrhagic and myotoxic activities induced by Bothrops pauloensis venom (Pb) was investigated. For this, we use samples resulting from the incubation of Pb with ISO in different concentrations (1:1, 1:5 and 1:10 w/w), we also evaluated the condition of treatment using ISO after 15 min of venom inoculation. The activities of phospholipase A₂, coagulant, fibrinogenolytic, hemorrhagic and myotoxic induced by the B. pauloensis venom were significantly inhibited when the ISO was pre-incubated with the crude venom. For in vivo neutralization tests, the results were observed even when the ISO was applied after 15 min of inoculation of the venom or metalloprotease (BthMP). Also, to identify the inhibition mechanism, we performed in silico assays, across simulations of molecular coupling and molecular dynamics, it was possible to identify the modes of interaction between ISO and bothropic toxins BmooMPα-I, Jararacussin-I and BNSP-7. The present study shows that naphthoquinone isohemigossypolone isolated from the P. aquatica plant inhibited part of the local and systemic damage caused by venom proteins, demonstrating the pharmacological potential of this compound in neutralizing the harmful effects caused by snakebites.

100 Deals associated with AbGn-7

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	TW	AbGenomics B.V Taiwan Branch	01 Nov 2011
Advanced Malignant Solid Neoplasm	Phase 1	US	AbGenomics B.V Taiwan Branch	01 Nov 2011
Glandular and Epithelial Neoplasms	Phase 1	US	AbGenomics B.V Taiwan Branch	01 Nov 2011
Glandular and Epithelial Neoplasms	Phase 1	TW	AbGenomics B.V Taiwan Branch	01 Nov 2011
Stomach Cancer	Phase 1	TW	AbGenomics International, Inc.	-
Stomach Cancer	Phase 1	TW	AbGenomics International, Inc.	-
Stomach Cancer	Phase 1	US	AbGenomics International, Inc.	-
Stomach Cancer	Phase 1	US	AbGenomics International, Inc.	-

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