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

Primary Purpose

Melanoma, Breast Carcinoma, Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XmAb20717
Sponsored by
Xencor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • UCLA Hematology-Oncology Clinic (Westwood)
  • University of California San Diego Moores Cancer Center
  • University of California San Francisco Medical Center
  • Emory University
  • University of Chicago Medicine
  • The University of Kansas Clinical Research Center
  • Karmanos Cancer Institute
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Columbia University Medical Center - Herbert Irving Pavilion
  • Providence Portland Medical Center
  • Hospital of the University of Pennsylvania
  • UPMC Hillman Cancer Center
  • The University of Texas MD Anderson Cancer Center
  • University of Utah, Huntsman Cancer Institute
  • Emily Couric Clinical Cancer Center
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XmAb20717

Arm Description

XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles

Outcomes

Primary Outcome Measures

Determine the safety and tolerability profile of XmAb20717
Treatment-related adverse events as assessed by CTCAE v4.03

Secondary Outcome Measures

Full Information

First Posted
April 23, 2018
Last Updated
November 29, 2022
Sponsor
Xencor, Inc.
Collaborators
ICON plc
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1. Study Identification

Unique Protocol Identification Number
NCT03517488
Brief Title
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
Acronym
DUET-2
Official Title
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
September 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.
Collaborators
ICON plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XmAb20717
Arm Type
Experimental
Arm Description
XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles
Intervention Type
Biological
Intervention Name(s)
XmAb20717
Intervention Description
Monoclonal bispecific antibody
Primary Outcome Measure Information:
Title
Determine the safety and tolerability profile of XmAb20717
Description
Treatment-related adverse events as assessed by CTCAE v4.03
Time Frame
56 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors: PART A (Dose Escalation Cohorts) 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 Mesothelioma; High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung Cervical cancer; Squamous cell carcinoma of the anus PART B (Dose Expansion Cohorts): Melanoma Renal cell carcinoma (clear cell predominant type) Non-small cell lung carcinoma 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) Nasopharyngeal carcinoma Cholangiocarcinoma Basal cell carcinoma Squamous cell carcinoma of the anus Mesothelioma Ovarian or fallopian tube carcinoma 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) Thymoma Thymic carcinoma Squamous cell carcinoma of the penis Neuroendocrine carcinoma Vulvar cancer Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zequn Tang, MD
Organizational Affiliation
Xencor, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Hematology-Oncology Clinic (Westwood)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Diego Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Kansas Clinical Research Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center - Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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