Clinical Trials /

A Study of XmAb®18087 in Subjects With NET and GIST

NCT03411915

Description:

This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST. The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion cohorts to collect additional data on safety and potential efficacy of XmAb18087.

Related Conditions:
  • Gastrointestinal Neuroendocrine Tumors
  • Gastrointestinal Stromal Tumor
  • Lung Neuroendocrine Neoplasm
  • Neuroendocrine Tumor, NOS
  • Pancreatic Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of XmAb®18087 in Subjects With NET and GIST
  • Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®18087 in Subjects With Advanced Neuroendocrine and Gastrointestinal Stromal Tumors (DUET-1)

Clinical Trial IDs

  • ORG STUDY ID: XmAb18087-01
  • SECONDARY ID: DUET-1
  • NCT ID: NCT03411915

Conditions

  • Neuroendocrine Tumor
  • Gastrointestinal Neoplasm

Interventions

DrugSynonymsArms
XmAb18087XmAb18087

Purpose

This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST. The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion cohorts to collect additional data on safety and potential efficacy of XmAb18087.

Trial Arms

NameTypeDescriptionInterventions
XmAb18087ExperimentalXmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
  • XmAb18087

Eligibility Criteria

        Inclusion Criteria:

          -  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 that is locally advanced or metastatic
             and has progressed within the past 12 months

          -  Histologically confirmed GIST that is locally advanced or metastatic

          -  NET and GIST tumors must be unresectable

          -  NET subjects must have progressed on or been ineligible for treatment with
             somatostatin analogues (SSA) and at least one other FDA-approved targeted therapy
             (everolimus or sunitinib).

          -  GIST subjects must have previously received all FDA-approved therapies (imatinib
             mesylate, sunitinib malate, and regorafenib) for which they are eligible

          -  Must have disease measurable by RECIST 1.1 criteria using either computed tomography
             (CT) or magnetic resonance imaging (MRI) scan

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Diagnosis of high-grade (WHO Grade 3) or poorly differentiated NET; high-grade
             neuroendocrine carcinoma; large cell neuroendocrine carcinoma, small cell carcinoma,
             or mixed small and large cell carcinoma.

          -  Subjects currently receiving anti-cancer therapies (other than SSAs, which may
             continue).

          -  Subjects who have received anti-cancer therapies within 2 weeks of the start of study
             drug (including chemotherapy, radiation therapy, immunotherapy, etc.).

          -  Must not be experiencing a Grade 3 or 4 toxicity from previous anti-cancer treatment

          -  Must not be receiving other anti-cancer therapies (except somatostatin analogues,
             which may be allowed)

          -  Must not have poorly controlled diabetes mellitus, known central nervous system
             involvement by malignant disease or insufficient bone marrow, renal, or hepatic
             function
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the safety and tolerability profile of XmAb18087
Time Frame:84 Days
Safety Issue:
Description:Treatment-related adverse events as assessed by CTCAE v4.03

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Xencor, Inc.

Trial Keywords

  • NET
  • GIST
  • DUET-1

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