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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 : October 7, 2019
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 26, 2018
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2018)
Treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 56 Days ]
Safety and tolerability
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03752398 on 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®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
Official Title  ICMJE A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors
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 in subjects with selected advanced solid tumors.
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
  • 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
Intervention  ICMJE Biological: XmAb®23104
Monoclonal bispecific antibody
Study Arms  ICMJE Experimental: XmAb®23104
XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
Intervention: Biological: XmAb®23104
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

    1. Histologically or cytologically confirmed advanced solid tumors, including the following:
    2. Melanoma (excluding uveal melanoma)
    3. Cervical carcinoma
    4. Pancreatic carcinoma
    5. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (TNBC)
    6. Hepatocellular carcinoma
    7. Urothelial carcinoma
    8. Squamous cell carcinoma of the head and neck (HNSCC)
    9. Nasopharyngeal carcinoma (NPC)
    10. Renal cell carcinoma
    11. Colorectal carcinoma
    12. Endometrial carcinoma
    13. NSCLC
    14. Small cell lung cancer
    15. Gastric or gastroesophageal junction adenocarcinoma
  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. TNBC
    3. HNSCC
    4. NPC
  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 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.
  6. Subjects have an ECOG performance status of 0-1.

Exclusion Criteria:

  1. Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
  2. Prior treatment with an investigational anti-ICOS therapy
  3. Treatment with nivolumab within 4 weeks of the start of study drug
  4. Treatment with pembrolizumab within < 6 - 24 weeks prior to enrollment (cohort dependent)
  5. Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
  6. A life-threatening (Grade 4) IRAE related to prior immunotherapy
  7. Failure to recover from any IRAE from prior cancer therapy to Grade ≤ 1
  8. Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
  9. 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)
  10. Receipt of an organ allograft
  11. 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
  12. Treatment with antibiotics within 14 days prior to first dose of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Liebowitz, MD 858-617-6160
Contact: Phuong Lee 858-480-3115
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03752398
Other Study ID Numbers  ICMJE XmAb23104-01
DUET-3 ( Other Identifier: Xencor, Inc. )
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: David Liebowitz, MD Xencor, Inc.
PRS Account Xencor, Inc.
Verification Date October 2019

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