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Clinical Trial Record

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

2019-05-01

2024-02-15

2024-02-15

198

Study Overview

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

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.

N/A

  • 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)
  • XmAb23104-01
  • DUET-3 (OTHER Identifier) (OTHER: 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 Registration Dates Results Reporting Dates Study Record Updates

2018-11-20  

N/A  

2024-07-02  

2018-11-23  

N/A  

2024-07-05  

2018-11-26  

N/A  

2024-07  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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 MeasuresMeasure DescriptionTime Frame
Treatment-related adverse events as assessed by CTCAE v4.03Safety and tolerability56 Days
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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

  • ICON plc
  • STUDY_DIRECTOR: Chet Bohac, MD, MSc, Xencor, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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