Clinical Trial (Phase 1 Study) of Tidutamab in Neuroendocrine Tumors (DUET-1)

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clinical trial TIDUTAMABXencor, a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, today announced that initial data from its ongoing Phase 1 dose-escalation study of tidutamab (XmAb®18087), an SSTR2 x CD3 bispecific antibody, in patients with neuroendocrine tumors (NETs) will be presented during the upcoming North American Neuroendocrine Tumor Society’s 2020 Multidisciplinary NET Medical Virtual Symposium.

About Tidutamab

Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells, i.e. they are an immunotherapy.  Tidutamab (XmAb®18087) is a tumor-targeted bispecific antibody that contains both an SSTR2 binding domain and a T-cell binding domain (CD3). An XmAb® bispecific Fc domain serves as the scaffold for the two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on tidutamab. SSTR2 (somatostatin receptor 2) is an antigen highly expressed on some solid tumors, and engagement of CD3 by tidutamab activates T cells for highly potent and targeted killing of SSTR2-expressing tumor cells. Tidutamab is being evaluated in an ongoing Phase 1 study, which is enrolling patients with neuroendocrine tumors (NETs) and gastrointestinal stromal tumors (GISTs). As this is an SSTR targeted therapy, it follows that it is designed to work with well differentiated NETs which have not yet been well served by the introduction of immunotherapy

About the Clinical Trial

The clinical trial is listed in Clinical Trials dot Gov under number NCT03411915 with a title of “A Study of XmAb®18087 in Subjects With NET and GIST“.  It is recruiting and they are looking for 87 participants. This is a Phase 1, multiple dose, ascending dose escalation study; to define a dose tolerance and a regimen consisting of a first “priming” dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK (pharmacokinetic) and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST. Which NET types qualify?  Histologically or cytologically confirmed well differentiated low or intermediate grade (World Health Organization [WHO] Grade 1 or 2) NET of pancreatic, gastrointestinal, lung, or undetermined origin (unknown primary) that is locally advanced or metastatic and has progressed within the past 12 months.  And histologically confirmed GIST that is locally advanced or metastatic.  Other inclusion requirements exist and can be found in the clinical trials documentWhere is the trial conducted?   There are currently 16 sites across the US, they all look like well-known hospitals for treating NETs.  The full list is in the clinical trials document

About Xencor, Inc.

Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases. Currently, 18 candidates engineered with Xencor’s XmAb® technology are in clinical development internally and with partners. Xencor’s XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.

Xencor to Present Initial Data from the Phase 1 Study of Tidutamab in Neuroendocrine Tumors at NANETS’ Multidisciplinary NET Medical Virtual Symposium

Presentation Details An abstract (#111) and a poster with initial data from the study will become available in the NANETS Virtual Poster Hall on Friday, October 2, 2020 at 9:00 a.m. ET. The abstract was also selected to be presented in an oral session:

  • Title: Preliminary Safety, PK/PD, and Antitumor Activity of XmAb18087, an SSTR2 x CD3 Bispecific Antibody, in Patients with Advanced Neuroendocrine Tumors
  • Presenter: Bassel El-Rayes, M.D., Professor and Vice Chair for Clinical Research of the Department of Hematology and Medical Oncology at Emory University School of Medicine, as well as Director of the Gastrointestinal Oncology Program at Winship Cancer Institute
  • Session: Clinical Abstracts
  • Date & Time: Saturday, October 3, 2020, 2:00 p.m. ET

For new of other carefully selected clinical trials for Neuroendocrine Neoplasms, please check my clinical trials archive by clicking herePlease also note that any mention of a clinical service, clinical trial or therapy does not constitute an endorsement of that service, trial/study or product by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience.

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Ronny

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