Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
ConditionClear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorXencor, Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- XmAb819
Treatment groups
307 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov