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A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (DUET-2)

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ClinicalTrials.gov Identifier: NCT03517488
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Brief Summary:
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

Condition or disease Intervention/treatment Phase
Melanoma Breast Carcinoma Hepatocellular Carcinoma Urothelial Carcinoma Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma Colorectal Carcinoma Non-small Cell Lung Carcinoma Gastric or Gastroesophageal Junction Adenocarcinoma Endometrial Carcinoma Mesothelioma Neuroendocrine Carcinoma Cervical Cancer Small Cell Lung Carcinoma Squamous Cell Carcinoma of the Anus Biological: XmAb20717 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: XmAb20717
XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles
Biological: XmAb20717
Monoclonal bispecific antibody




Primary Outcome Measures :
  1. Determine the safety and tolerability profile of XmAb20717 [ Time Frame: 56 Days ]
    Treatment-related adverse events as assessed by CTCAE v4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced solid tumors including:

    • Melanoma;
    • Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
    • Hepatocellular carcinoma;
    • Urothelial carcinoma;
    • Squamous cell carcinoma of the head and neck;
    • Renal cell carcinoma (clear cell predominant type);
    • Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
    • Non-small cell lung carcinoma;
    • Gastric or gastroesophageal junction adenocarcinoma
    • Mesothelioma;
    • High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
    • Cervical cancer;
    • Squamous cell carcinoma of the anus
  • All subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.
  • Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
  • Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug.
  • Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent).
  • Subjects currently receiving other anticancer therapies.
  • Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
  • A life-threatening (Grade 4) immune-mediated adverse event related to prior immunotherapy.
  • Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1, except if previous immune-related endocrinopathy is medically managed with hormone replacement therapy only.
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
  • Have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging, are clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).
  • Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted).
  • Receipt of an organ allograft.
  • Treatment with antibiotics within 14 days prior to first dose of study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517488


Contacts
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Contact: Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com
Contact: Jennifer Ely 858-480-3125 jely@xencor.com

Locations
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United States, California
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Recruiting
Los Angeles, California, United States, 90048
UCLA Hematology-Oncology Clinic (Westwood) Recruiting
Los Angeles, California, United States, 90095
University of California San Diego Moores Cancer Center Recruiting
San Diego, California, United States, 92093-0698
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94115
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
The University of Kansas Clinical Research Center Recruiting
Fairway, Kansas, United States, 66205
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Columbia University Medical Center - Herbert Irving Pavilion Recruiting
New York, New York, United States, 10032
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Emily Couric Clinical Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Xencor, Inc.
ICON plc
Investigators
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Study Director: Barbara Hickingbottom, MD Xencor, Inc.

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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT03517488     History of Changes
Other Study ID Numbers: XmAb20717-01
DUET-2 ( Other Identifier: Xencor, Inc. )
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xencor, Inc.:
DUET-2
Melanoma
Triple Negative Breast Cancer
Hepatocellular Cancer
Urothelial Cancer
Bladder Cancer
Renal Cell Cancer
Head and Neck Cancer
MSI-high Colorectal Cancer
MSI-high Endometrial Cancer
Non-small Cell Lung Cancer
Gastric Cancer
Gastroesophageal Junction Cancer
Mesothelioma
High-grade Neuroendocrine Cancer
Cervical Cancer
Small Cell Lung Cancer
Anal Cancer

Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Hepatocellular
Uterine Cervical Neoplasms
Carcinoma, Renal Cell
Mesothelioma
Breast Neoplasms
Lung Neoplasms
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Endometrial Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Esophageal Neoplasms
Carcinoma, Neuroendocrine
Small Cell Lung Carcinoma
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Liver Neoplasms
Digestive System Neoplasms