Clinical Trials /

A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

NCT03517488

Description:

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Endometrial Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
  • Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: XmAb20717-01
  • SECONDARY ID: DUET-2
  • NCT ID: NCT03517488

Conditions

  • Melanoma
  • Breast Carcinoma
  • Hepatocellular Carcinoma
  • Urothelial Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Renal Cell Carcinoma
  • Colorectal Carcinoma
  • Non-small Cell Lung Carcinoma
  • Gastric or Gastroesophageal Junction Adenocarcinoma
  • Endometrial Carcinoma

Interventions

DrugSynonymsArms
XmAb20717XmAb20717

Purpose

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
XmAb20717ExperimentalXmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically or cytologically confirmed advanced solid tumors including:
    
                   -  Melanoma (excluding uveal melanoma);
    
                   -  Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2
                      negative (triple-negative breast cancer; TNBC);
    
                   -  Hepatocellular carcinoma;
    
                   -  Urothelial carcinoma;
    
                   -  Squamous cell carcinoma of the head and neck;
    
                   -  Renal cell carcinoma (clear cell predominant type);
    
                   -  Microsatellite instability-high or mismatch repair deficient colorectal carcinoma
                      or endometrial carcinoma;
    
                   -  Non-small cell lung carcinoma;
    
                   -  Gastric or gastroesophageal junction adenocarcinoma
    
              -  All subjects' cancer must have progressed after treatment with standard therapies or
                 have no appropriate available therapies.
    
              -  Have available archival formalin-fixed paraffin-embedded block(s) containing tumor or
                 at least 20 unstained slides containing tumor.
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    
            Exclusion Criteria:
    
              -  Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
    
              -  Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the
                 start of study drug.
    
              -  Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort
                 dependent).
    
              -  Subjects currently receiving other anticancer therapies.
    
              -  Treatment with any other anticancer therapy within 2 weeks of the start of study drug
                 (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
    
              -  A life-threatening (Grade 4) immune-mediated adverse event related to prior
                 immunotherapy.
    
              -  Failure to recover from any immune-related toxicity from prior cancer therapy to ≤
                 Grade 1.
    
              -  Failure to recover from any other toxicity (other than immune-related toxicity)
                 related to previous anticancer treatment to ≤ Grade 2.
    
              -  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).
    
              -  Has any condition requiring systemic treatment with corticosteroids, prednisone
                 equivalents, or other immunosuppressive medications within 14 days prior to first dose
                 of study drug (except that inhaled or topical corticosteroids or brief courses of
                 corticosteroids given for prophylaxis of contrast dye allergic response are
                 permitted).
    
              -  Receipt of an organ allograft.
    
              -  Treatment with antibiotics within 14 days prior to first dose of study drug.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Determine the safety and tolerability profile of XmAb20717
    Time Frame:56 Days
    Safety Issue:
    Description:Treatment-related adverse events as assessed by CTCAE v4.03

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Xencor, Inc.

    Trial Keywords

    • DUET-2
    • Melanoma
    • Triple Negative Breast Cancer
    • Hepatocellular
    • Urothelial Cancer
    • Bladder Cancer
    • Renal Cell Cancer
    • Head and Neck Cancer
    • MSI-high Colorectal Cancer
    • MSI-high Endometrial Cancer
    • Non-small Cell Lung Cancer
    • Gastric Cancer
    • Gastroesophageal Junction Cancer

    Last Updated