Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433142
• Other study ID #: XmAb819-01
• Status: Recruiting
• Phase: Phase 1
• Start date: June 13, 2022
• Est. completion date: March 2027

Study information

• Verified date: September 2023
• Source: Xencor, Inc.
• Contact: Chet Bohac, MD
• Phone: (626)305-5900
• Email: cbohac[@]xencor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: March 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Biological:
• XmAb819
Monoclonal Bispecific Antibody

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Department of Medical Oncology and Therapeutics Research, City of Hope	Duarte	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute, LLC	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Xencor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Primary	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.	28 days
Secondary	Measurement of Cmax	Peak plasma concentration (Cmax)	56 days
Secondary	Measurement of AUCtau	Area under the plasma concentration versus time curve (AUCtau)	56 days
Secondary	Objective Response rate	Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)	42 days
Secondary	Progression-free survival	Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)	42 days
Secondary	Duration of response	Duration of response (RECIST 1.1 assessment of CT/MRI imaging)	42 days