Back to resultsStudy of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Primary Purpose
Clear Cell Renal Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XmAb819
Sponsored by
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring ccRCC, RCC, Renal Cell Cancer, Kidney Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator or radiology department
- Subjects who have relapsed and refractory ccRCC and had undergone disease progression on standard-of-care therapies
- ECOG performance status of 0 or 1
- All subjects in Part B, dose expansion, must have a tumor lesion that can be biopsied and must agree to a fresh biopsy during screening and second biopsy to be collected between Days 1 to 8 of Cycle 2
- All subjects in Part A, dose escalation, must have adequate tumor sample (slides or archival FFPE blocks). Expected are subjects who consent to having a fresh tumor biopsy to provide a fresh tumor sample instead of the archival tumor sample
Exclusion Criteria:
- Prior treatment with an investigational anti-ENPP3/CD203c therapy
- History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
- Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
- Failure to recover from any clinically significant toxicity related to previous anticancer treatment
- Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
- Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; 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 nonsteroidal anti-inflammatory drugs)
- Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
- Have a known additional malignancy that is progressing or has required active treatment within the past 2 years
Sites / Locations
- Department of Medical Oncology and Therapeutics Research, City of HopeRecruiting
- Winship Cancer Institute of Emory UniversityRecruiting
- The University of Chicago Medical CenterRecruiting
- Columbia University Medical CenterRecruiting
- Memorial Sloan KetteringRecruiting
- Fox Chase Cancer CenterRecruiting
- Sarah Cannon Research Institute, LLCRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation and Expansion
Arm Description
Dose Escalation (Part A): Part A will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC in subjects with ccRCC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose. Dose Expansion (Part B): Part B-1 may administer XmAb819 IV, and Part B-2 may administer XmAb819 SC.
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Incidence of dose limiting toxicities (DLTs)
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
Secondary Outcome Measures
Measurement of Cmax
Peak plasma concentration (Cmax)
Measurement of AUCtau
Area under the plasma concentration versus time curve (AUCtau)
Objective Response rate
Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)
Progression-free survival
Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)
Duration of response
Duration of response (RECIST 1.1 assessment of CT/MRI imaging)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433142
Brief Title
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Official Title
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.
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
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
Detailed Description
This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after standard therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma
Keywords
ccRCC, RCC, Renal Cell Cancer, Kidney Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation and Expansion
Arm Type
Experimental
Arm Description
Dose Escalation (Part A): Part A will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC in subjects with ccRCC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose.
Dose Expansion (Part B): Part B-1 may administer XmAb819 IV, and Part B-2 may administer XmAb819 SC.
Intervention Type
Biological
Intervention Name(s)
XmAb819
Intervention Description
Monoclonal Bispecific Antibody
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Description
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Time Frame
28 days
Title
Incidence of dose limiting toxicities (DLTs)
Description
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Measurement of Cmax
Description
Peak plasma concentration (Cmax)
Time Frame
56 days
Title
Measurement of AUCtau
Description
Area under the plasma concentration versus time curve (AUCtau)
Time Frame
56 days
Title
Objective Response rate
Description
Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)
Time Frame
42 days
Title
Progression-free survival
Description
Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)
Time Frame
42 days
Title
Duration of response
Description
Duration of response (RECIST 1.1 assessment of CT/MRI imaging)
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
ECOG performance status of 0 or 1.
All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
Exclusion Criteria:
Prior treatment with an investigational anti-ENPP3/CD203c therapy
History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
Failure to recover from any clinically significant toxicity related to previous anticancer treatment
Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; 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 nonsteroidal anti-inflammatory drugs)
Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
Have a known additional malignancy that is progressing or has required active treatment within the past 2 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chet Bohac, MD
Phone
(626)305-5900
Email
cbohac@xencor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Finnigan
Email
lfinnigan@xencor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chet Bohac, MD
Organizational Affiliation
Xencor, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Department of Medical Oncology and Therapeutics Research, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
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