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A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (DUET-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03752398
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : September 22, 2021
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 XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.

Condition or disease Intervention/treatment Phase
Melanoma (Excluding Uveal Melanoma) Cervical Carcinoma Pancreatic Carcinoma Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative Hepatocellular Carcinoma Urothelial Carcinoma Squamous Cell Carcinoma of the Head and Neck Nasopharyngeal Carcinoma Renal Cell Carcinoma Colorectal Carcinoma Endometrial Carcinoma Non-small Cell Lung Carcinoma Small Cell Lung Cancer Gastric or Gastroesophageal Junction Adenocarcinoma Advanced Solid Tumors Undifferentiated Pleomorphic Sarcoma Biological: XmAb®23104 Biological: Yervoy® (ipilimumab) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
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®23104 in Subjects With Selected Advanced Solid Tumors
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: XmAb®23104 Monotherapy
XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
Biological: XmAb®23104
Monoclonal bispecific antibody

Experimental: XmAb®23104 Combination Therapy with Ipilimumab
XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)
Biological: XmAb®23104
Monoclonal bispecific antibody

Biological: Yervoy® (ipilimumab)
Monoclonal antibody

Primary Outcome Measures :
  1. Treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 56 Days ]
    Safety and tolerability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:

    Histologically or cytologically confirmed advanced solid tumors, including the following:

    1. Melanoma (excluding uveal melanoma)
    2. Cervical carcinoma
    3. Pancreatic carcinoma
    4. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
    5. Hepatocellular carcinoma
    6. Urothelial carcinoma
    7. Squamous cell carcinoma of the head and neck
    8. Nasopharyngeal carcinoma
    9. Renal cell carcinoma
    10. Colorectal carcinoma
    11. Endometrial carcinoma
    12. NSCLC
    13. Small cell lung cancer
    14. Gastric or gastroesophageal junction adenocarcinoma
    15. Sarcoma
  2. Subjects in Part B (expansion) must have a diagnosis of any of the following:

    Histologically or cytologically confirmed advanced solid tumors of the following types:

    1. Non-squamous NSCLC
    2. Melanoma
    3. HNSCC, including NPC
    4. CRC
    5. UPS, including other select high grade STS, such as MFS
    6. ccRCC

    Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:

    1. Non-squamous NSCLC
    2. Melanoma
    3. HNSCC, including NPC
    4. CRC
    5. UPS, including other select high-grade STS such as MFS
    6. RCC, clear cell histology (ccRCC)
  3. All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
  4. Subjects must have measurable disease by RECIST 1.1.
  5. All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
  6. All subjects in Part B (dose expansion) must have a tumor lesion that can be biopsied at acceptable risk (in the judgment of the Investigator) and must agree to both a fresh biopsy during screening and a second biopsy following treatment.
  7. Subjects have an ECOG performance status of 0-1.

Exclusion Criteria:

  1. Currently receiving other anticancer therapies
  2. Prior treatment with an investigational anti-ICOS therapy
  3. Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
  4. Treatment with nivolumab within 4 weeks of the start of study drug
  5. Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
  6. Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
  7. A life-threatening (Grade 4) irAE related to prior immunotherapy
  8. Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for endocrinopathies that are on stable hormone replacement doses
  9. Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
  10. Known active central nervous system involvement by malignant disease. Subjects 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 and are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  11. Active known or suspected autoimmune disease
  12. Receipt of an organ allograft
  13. History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
  14. Treatment with antibiotics within 14 days prior to first dose of study drug
  15. Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted).
  16. Treatment with ipilimumab within 4 weeks of the start 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 identifier (NCT number): NCT03752398

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Contact: Ben Thompson, MD, PhD 619 571-7381
Contact: Amber Sarot 858-245-9419

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United States, California
UC San Diego Moores Cancer Center Recruiting
San Diego, California, United States, 92093
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University School of Medicine Siteman Cancer Center Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Mary Crowley Cancer Research - Medical City Recruiting
Dallas, Texas, United States, 75230
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah, Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
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
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Study Director: Ben Thompson, MD, PhD Xencor, Inc.
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Responsible Party: Xencor, Inc. Identifier: NCT03752398    
Other Study ID Numbers: XmAb23104-01
DUET-3 ( Other Identifier: Xencor, Inc. )
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
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.:
Advanced solid tumors
Cervical Cancer
Pancreatic Cancer
Triple Negative Breast Cancer
Hepatocellular/Liver Cancer
Urothelial Cancer
Bladder Cancer
Renal Cell Cancer
Head and Neck Cancer
Colorectal Cancer
Endometrial Cancer
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Gastric Cancer
Gastroesophageal Junction Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Nasopharyngeal Carcinoma
Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Endometrial Neoplasms
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Histiocytoma, Malignant Fibrous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carcinoma, Squamous Cell
Neoplasms, Connective and Soft Tissue
Digestive System Neoplasms
Digestive System Diseases