Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XmAb819.
- Who it may be relevant to
- Registry conditions: Clear Cell Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Biological XmAb819
Monoclonal Bispecific Antibody
Primary outcome measures
- Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) [Time frame: 28 days]
- Incidence of dose limiting toxicities (DLTs) [Time frame: 28 days]
Secondary outcome measures (5)
- Measurement of Cmax [Time frame: 56 days]
- Measurement of AUCtau [Time frame: 56 days]
- Objective Response rate [Time frame: 42 days]
- Progression-free survival [Time frame: 42 days]
- Duration of response [Time frame: 42 days]
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, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Xencor Investigative Site — Phoenix
- Xencor Investigative Site — Duarte
- Xencor Investigative Site — Sacramento
- Xencor Investigative Site — New Haven
- Xencor Investigative Site — Jacksonville
- Xencor Investigative Site — Atlanta
- Xencor Investigative Site — Chicago
- Xencor Investigative Site — Chicago
- … and 12 more centers
France · 2 centers
- Xencor Investigative Site — Bourdeaux
- Xencor Investigative Site — Villejuif
Spain · 2 centers
- Xencor Investigative Site — Barcelona
- Xencor Investigative Site — Madrid
Belgium · 1 center
- Xencor Investigative Site — Leuven
United Kingdom · 1 center
- Xencor Investigative Site — Cambridge
Identifiers
NCT: NCT05433142 · XmAb819-01