Clear Cell Renal Cell Carcinoma
Conditions
Keywords
Clear cell Papillary, RCC, Renal Cell Cancer, Kidney Cancer, Lung Cancer, Colon Cancer
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: dose escalation, and 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 and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.
Interventions
BIOLOGICALXmAb819
Monoclonal Bispecific Antibody
Sponsors
Xencor, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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, pRCC, NSCLC, and CRC 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) | 28 days | 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) | 28 days | Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Cmax | 56 days | Peak plasma concentration (Cmax) |
| Measurement of AUCtau | 56 days | Area under the plasma concentration versus time curve (AUCtau) |
| Objective Response rate | 42 days | Objective response rate (RECIST 1.1 assessment of CT/MRI imaging) |
| Progression-free survival | 42 days | Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging) |
| Duration of response | 42 days | Duration of response (RECIST 1.1 assessment of CT/MRI imaging) |
Countries
Belgium, France, Spain, United Kingdom, United States
Contacts
CONTACT819-01 Study Information
STUDY_DIRECTOR819-01 Study Information
Xencor, Inc.
Outcome results
None listed