Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411915
Other study ID # XmAb18087-01
Secondary ID DUET-1
Status Completed
Phase Phase 1
First received
Last updated
Start date January 22, 2018
Est. completion date October 26, 2021

Study information

Verified date May 2022
Source Xencor, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date October 26, 2021
Est. primary completion date October 26, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Intervention

Biological:
XmAb18087
monoclonal bispecific antibody

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States University of Colorado, Anschutz Medical Campus Aurora Colorado
United States Dana-Farber Cancer Institute Boston Massachusetts
United States University of Virginia Charlottesville Virginia
United States Northwestern Medicine Chicago Illinois
United States James Cancer Center Columbus Ohio
United States City of Hope Medical Center Duarte California
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Jacksonville Florida
United States Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California
United States Memorial Sloan Kettering Cancer Center New York New York
United States Stanford Cancer Center Palo Alto California
United States University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Phoenix Arizona
United States Mayo Clinic Rochester Minnesota
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Xencor, Inc. ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the safety and tolerability profile of XmAb18087 Treatment-related adverse events as assessed by CTCAE v4.03 84 Days
Primary Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients 84 Days
See also
  Status Clinical Trial Phase
Recruiting NCT04837885 - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases Phase 2
Completed NCT00789841 - Gastrointestinal Motility in Patients With Neuroendocrine Tumors N/A
Recruiting NCT05069220 - 18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor Early Phase 1
Completed NCT05816720 - Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT01849523 - Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study N/A
Recruiting NCT01448083 - Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours N/A
Completed NCT00804336 - Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors Phase 1
Active, not recruiting NCT02092714 - Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors
Terminated NCT04073017 - Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency N/A
Completed NCT00434109 - Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization Phase 2
Completed NCT02472678 - Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor N/A
Completed NCT02481804 - Optimal Feeding for NET Patients N/A
Completed NCT02147106 - Use of Video Consultation in Follow-up Care for Patients With a Neuroendocrine Tumor: a Feasibility Study
Completed NCT00165230 - Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors Phase 2
Active, not recruiting NCT03012789 - Surgical Intervention and the NETest N/A
Not yet recruiting NCT02038738 - 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors Phase 1/Phase 2
Completed NCT01024387 - AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Phase 2
Terminated NCT00227617 - Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors Phase 2/Phase 3