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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 : May 14, 2020
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 7, 2018
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE July 10, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2018)		 Determine the safety and tolerability profile of XmAb20717 [ Time Frame: 56 Days ]
Treatment-related adverse events as assessed by CTCAE v4.03
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Biological: XmAb20717
Monoclonal bispecific antibody
Study Arms  ICMJE Experimental: XmAb20717
XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles
Intervention: Biological: XmAb20717
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)		 154
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2018)		 87
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com
Contact: Jennifer Ely 858-480-3125 jely@xencor.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03517488
Other Study ID Numbers  ICMJE XmAb20717-01
DUET-2 ( Other Identifier: Xencor, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xencor, Inc.
Study Sponsor  ICMJE Xencor, Inc.
Collaborators  ICMJE ICON plc
Investigators  ICMJE
Study Director: Barbara Hickingbottom, MD Xencor, Inc.
PRS Account Xencor, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP