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

July 2, 2024 updated by: Xencor, Inc.

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • UC San Diego Moores Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute at HealthONE
    • Florida
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Siteman Cancer Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research - Medical City
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Emily Couric Clinical Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: 56 Days
Safety and tolerability
56 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xencor, Inc.

Collaborators

ICON plc

Investigators

  • Study Director: Chet Bohac, MD, MSc, Xencor, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XmAb23104-01
  • DUET-3 (Other Identifier: Xencor, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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