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A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (DUET-2)

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: NCT03517488
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : April 11, 2022
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 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.

Condition or disease Intervention/treatment Phase
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 Mesothelioma Neuroendocrine Carcinoma Cervical Cancer Small Cell Lung Carcinoma Squamous Cell Carcinoma of the Anus Castration-Resistant Prostate Carcinoma Nasopharyngeal Carcinoma Cholangiocarcinoma Basal Cell Carcinoma Ovarian Carcinoma Fallopian Tube Carcinoma Thymoma Thymic Carcinoma Squamous Cell Carcinoma of the Penis Vulvar Carcinoma Solid Tumors With Published Evidence of Anti-tumor Activity With Anti-PD1/PDL1 and/or Anti-CTLA4-directed Therapy Malignant Adnexal Neoplasms Non-squamous Cell Salivary Gland Carcinoma Biological: XmAb20717 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: N/A
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®20717 in Subjects With Selected Advanced Solid Tumors
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: XmAb20717
XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles
 Biological: XmAb20717
Monoclonal bispecific antibody


Outcome Measures
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Primary Outcome Measures :
  1. Determine the safety and tolerability profile of XmAb20717 [ Time Frame: 56 Days ]
    Treatment-related adverse events as assessed by CTCAE v4.03


Eligibility Criteria
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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:

  • Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors:

PART A (Dose Escalation Cohorts)

  1. Melanoma;
  2. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
  3. Hepatocellular carcinoma;
  4. Urothelial carcinoma;
  5. Squamous cell carcinoma of the head and neck;
  6. Renal cell carcinoma (clear cell predominant type);
  7. Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
  8. Non-small cell lung carcinoma;
  9. Gastric or gastroesophageal junction adenocarcinoma
  10. Mesothelioma;
  11. High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
  12. Cervical cancer;
  13. Squamous cell carcinoma of the anus

PART B (Dose Expansion Cohorts):

  1. Melanoma
  2. Renal cell carcinoma (clear cell predominant type)
  3. Non-small cell lung carcinoma
  4. Castrate-resistant adenocarcinoma of the prostate, defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL)
  5. Nasopharyngeal carcinoma
  6. Cholangiocarcinoma
  7. Basal cell carcinoma
  8. Squamous cell carcinoma of the anus
  9. Mesothelioma
  10. Ovarian or fallopian tube carcinoma
  11. Malignant adnexal neoplasms (including, but not limited to, sebaceous carcinoma, trichilemmal carcinoma, pilomatrix carcinoma, eccrine carcinoma, hidradenocarcinoma, adnexal carcinoma with divergent differentiation, papillary digital eccrine adenocarcinoma, microcystic adnexal carcinoma, and clear cell eccrine carcinoma)
  12. Thymoma
  13. Thymic carcinoma
  14. Squamous cell carcinoma of the penis
  15. Neuroendocrine carcinoma
  16. Vulvar cancer
  17. Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma)

  18. Subjects with other solid tumors for which there is published evidence of anti-tumor activity with anti-PD1/PDL1 and/or anti-CTLA4-directed therapy but for which there is no FDA-approved anti-PD1/PDL1 or CTLA4-directed checkpoint inhibitor treatment may be eligible for Part B after approval by the Medical Monitor.

    • All subjects' cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies.
    • Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.1.
    • Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
    • ECOG performance status of 0 - 1
    • Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3.

Exclusion Criteria:

  • Subjects currently receiving other anticancer therapies, with the exception of subjects with adenocarcinoma of the prostate, who may continue luteinizing hormone-releasing hormone (LHRH) analogue therapy.
  • 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).
  • Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.). Subjects with prostate cancer may continue LHRH analogue therapy.
  • A life-threatening (Grade 4) immune-mediated AE related to prior immunotherapy.
  • Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1, except if previous immune-related endocrinopathy is medically managed with hormone replacement therapy only.
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
  • Have known active CNS metastases and/or carcinomatous meningitis. Participants 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, are clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • 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.
  • Prior treatment with any checkpoint inhibitor therapy regimen that targets both PD1/L1 and CTLA-4.
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): NCT03517488


Contacts
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Contact: Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com
Contact: Jennifer Ely 858-480-3125 jely@xencor.com

Locations
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Sponsors and Collaborators
Xencor, Inc.
ICON plc
Investigators
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Study Director: Barbara Hickingbottom, MD Xencor, Inc.
More Information
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT03517488    
Other Study ID Numbers: XmAb20717-01
DUET-2 ( Other Identifier: Xencor, Inc. )
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
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-2
Melanoma
Triple Negative Breast Cancer
Hepatocellular Cancer
Urothelial 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
Mesothelioma
High-grade Neuroendocrine Cancer
 Cervical Cancer
Small Cell Lung Cancer
Anal Cancer
Prostate Cancer
Nasopharyngeal Cancer
Bile Duct Cancer
Basal Cell Skin Cancer
Ovarian Cancer
Fallopian Tube Cancer
Malignant Adnexal Tumor
Thymus Cancer
Penile Cancer
Vulvar Cancer
Salivary Gland Cancer
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Mesothelioma
Mesothelioma, Malignant
Nasopharyngeal Carcinoma
Cholangiocarcinoma
Breast Neoplasms
Lung Neoplasms
Carcinoma, Basal Cell
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Endometrial Neoplasms
Carcinoma, Non-Small-Cell Lung
 Carcinoma, Neuroendocrine
Thymoma
Small Cell Lung Carcinoma
Anus Neoplasms
Vulvar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Adenocarcinoma