ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03752398
Recruitment Status : Not yet recruiting
First Posted : November 26, 2018
Last Update Posted : November 26, 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 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.

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 Biological: XmAb®23104 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 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®23104 in Subjects With Selected Advanced Solid Tumors
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: XmAb®23104
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




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.


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

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

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): NCT03752398


Contacts
Contact: David Liebowitz, MD 858-617-6160 dliebowitz@xencor.com
Contact: Phuong Lee 858-480-3115 plee@xencor.com

Locations
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Xencor, Inc.
ICON plc
Investigators
Study Director: David Liebowitz, MD Xencor, Inc.

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT03752398     History of Changes
Other Study ID Numbers: XmAb23104-01
DUET-3 ( Other Identifier: Xencor, Inc. )
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 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-3
Advanced solid tumors
Melanoma
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:
Carcinoma
Lung Neoplasms
Melanoma
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Small Cell Lung Carcinoma
Breast Neoplasms
Nasopharyngeal Neoplasms
Carcinoma, Transitional Cell
Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Endometrial Neoplasms
Colorectal Neoplasms
Esophageal Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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