← Back to Search

Monoclonal Antibodies

XmAb®819 for Renal Cell Carcinoma

Phase 1

Recruiting

Research Sponsored by Xencor, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1.

Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Study Summary

This trial is testing a new antibody drug to treat renal cell cancer that has returned or does not respond to other treatments. The goal is to find the safest and most effective dose.

Who is the study for?

This trial is for adults with advanced clear cell renal cell carcinoma who have seen their cancer return or not respond to standard treatments. They must be relatively healthy (ECOG status 0 or 1), have a tumor sample available, and measurable disease. People can't join if they've had certain recent cancers, brain metastases, serious allergies to monoclonal antibodies, autoimmune diseases, or significant infections recently.Check my eligibility

What is being tested?

The study tests XmAb®819 given through IV or SC injections in patients with relapsed/refractory kidney cancer. It aims to find the safest and most effective dose that shows biological activity against the cancer.See study design

What are the potential side effects?

Possible side effects of XmAb®819 may include reactions at the injection site, general discomforts like fatigue and nausea, allergic responses similar to other antibody therapies, and potentially impacts on organ function which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My kidney cancer has returned and worsened despite treatment.

Select...

My cancer can be measured by scans and has grown in previously treated areas.

Select...

I have a tumor sample available for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose limiting toxicities (DLTs)

Therapeutic procedure

Secondary outcome measures

Duration of response

Measurement of AUCtau

Measurement of Cmax

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

Dose Escalation (Part A): Part A will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC in subjects with ccRCC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose. Dose Expansion (Part B): Part B-1 may administer XmAb819 IV, and Part B-2 may administer XmAb819 SC.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,658 Total Patients Enrolled

Gerry Bohac, MDStudy DirectorXencor, Inc.

Zequn (Tony) Tang, MD PhDStudy DirectorXencor, Inc.

Media Library

XmAb819 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05433142 — Phase 1

Renal Cell Carcinoma Research Study Groups: Dose Escalation and Expansion

Renal Cell Carcinoma Clinical Trial 2023: XmAb819 Highlights & Side Effects. Trial Name: NCT05433142 — Phase 1

XmAb819 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05433142 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do individuals face when using XmAb819?

"Data regarding XmAb819's safety and efficacy is minimal, so its score on the 1-3 scale was rated as a 1."

Answered by AI

How many participants is the research team recruiting for their investigation?

"Xencor, Inc. are the sponsors of this trial and need 95 volunteers that meet their eligibility criteria to commence it across two sites: Department of Medical Oncology and Therapeutics Research at City of Hope in Duarte, California; Sarah Cannon Research Institute LLC in Nashville, Tennessee."

Answered by AI

What are the principal goals of this clinical experiment?

"According to Xencor, Inc., the principal metric for this 28 day clinical trial is treatment-emergent adverse events. Additionally, secondary assessments will include an AUCtau analysis and a RECIST 1.1 assessment which measure response duration as well as area under concentration curves respectively."

Answered by AI

Is enrollment for this experiment currently open?

"Affirmative. The clinical trial was first advertised on June 13th 2022 and the most recent update came in November 1st of that same year. According to information available on clinicaltrials.gov, there are 95 participants being recruited across 3 sites for this ongoing medical study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05433142.

All > Renal Cell Carcinoma