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Study of XmAb®819 for Advanced Clear Cell Renal Cell Carcinoma

This study is testing a new treatment called XmAb®819, which is a monoclonal bispecific antibody, for people with advanced clear cell renal cell carcinoma (a type of kidney cancer). You might be able to join if your cancer has returned or hasn't responded to standard treatments, and if your disease can be measured by imaging tests. The main goals are to see how safe XmAb®819 is, what side effects it might cause, and to find the best dose. Researchers will also look for early signs of how well it works against the cancer. The study is currently recruiting participants.

Study design
This is a Phase 1, open-label study with two parts: dose escalation and dose expansion. It plans to enroll 307 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured for 28 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05433142

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Xencor, Inc.
~307 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:XmAb819

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Measured over 28 days
+1 more outcome measured

Conditions

Clear Cell Renal Cell Carcinoma

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Clear Cell Renal Cell CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaPapillary Renal Cell CarcinomaSolid Neoplasm

Where it's being run

26 sites across 19 states
California2
Illinois2
New York2
North Carolina2
Ohio2
France2
Spain2
Arizona1

Study leadership

  • 819-01 Study Information · STUDY_DIRECTOR · Xencor, Inc.

Who to contact

819-01 Study Information
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.