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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.
 
ClinicalTrials.gov Identifier: NCT03752398
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : March 28, 2023
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : December 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Arms and Interventions
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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


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


Eligibility Criteria
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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:

  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. Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch repair CRC with the following:

    1. cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies
    2. subjects will have life expectancy greater than 3 months
  4. All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
  5. Subjects must have measurable disease by RECIST 1.1.
  6. All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
  7. 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.
  8. 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
Contacts and Locations
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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
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Contact: Ben Thompson, MD, PhD 619 571-7381 bthompson@xencor.com
Contact: Amber Sarot 858-245-9419 asarot@xencor.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Xencor, Inc.
ICON plc
Investigators
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Study Director: Ben Thompson, MD, PhD Xencor, Inc.
More Information
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov 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: March 28, 2023
Last Verified: March 2023
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-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
Sarcoma
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Melanoma
Sarcoma
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
 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
Carcinoma, Squamous Cell
Digestive System Neoplasms
Digestive System Diseases
Neoplasms, Connective and Soft Tissue