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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 : November 29, 2018
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 Biological: XmAb20717 Phase 1

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 advanced solid tumors including:

    • Melanoma (excluding uveal 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
  • All subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.
  • Have available archival formalin-fixed paraffin-embedded block(s) containing tumor or at least 20 unstained slides containing tumor.
  • 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.
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
  • 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
Contact: Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com
Contact: Mike Lucas 858-617-6157 mlucas@xencor.com

Locations
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
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
Study Director: Barbara Hickingbottom, MD Xencor, Inc.

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: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
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

Additional relevant MeSH terms:
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Breast Neoplasms
Lung Neoplasms
Carcinoma, Transitional Cell
Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Endometrial Neoplasms
Colorectal Neoplasms
Esophageal 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
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Kidney Neoplasms
Urologic Neoplasms