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

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ClinicalTrials.gov Identifier: NCT03411915
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Tracking Information
First Submitted Date  ICMJE January 15, 2018
First Posted Date  ICMJE January 26, 2018
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE January 22, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • Determine the safety and tolerability profile of XmAb18087 [ Time Frame: 84 Days ]
    Treatment-related adverse events as assessed by CTCAE v4.03
  • Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 [ Time Frame: 84 Days ]
    Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03411915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of XmAb®18087 in Subjects With NET and GIST
Official Title  ICMJE 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)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumor
  • Gastrointestinal Neoplasm
Intervention  ICMJE Biological: XmAb18087
monoclonal bispecific antibody
Study Arms  ICMJE Experimental: XmAb18087
XmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
Intervention: Biological: XmAb18087
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2018)
87
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com
Contact: Jennifer Ely 858-480-3125, X225 jely@xencor.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03411915
Other Study ID Numbers  ICMJE XmAb18087-01
DUET-1 ( Other Identifier: Xencor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xencor, Inc.
Study Sponsor  ICMJE Xencor, Inc.
Collaborators  ICMJE ICON plc
Investigators  ICMJE
Study Director: Barbara Hickingbottom, MD Executive Director, Clinical Development, Xencor
PRS Account Xencor, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP