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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 belowSelect...
I am fully active or can carry out light work.
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My kidney cancer has returned and worsened despite treatment.
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My cancer can be measured by scans and has grown in previously treated areas.
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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
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 moreTrial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Renal Cell Carcinoma (RCC) include immune checkpoint inhibitors, tyrosine kinase inhibitors, and bispecific antibodies. Immune checkpoint inhibitors, such as nivolumab and pembrolizumab, work by blocking proteins like PD-1/PD-L1, which cancer cells use to evade the immune system, thereby enhancing the body's immune response against cancer cells.
Tyrosine kinase inhibitors, like sunitinib, inhibit enzymes that promote tumor growth and angiogenesis. Bispecific antibodies, such as those being studied in XmAb®819, are engineered to bind to both tumor antigens and immune cells, facilitating a more targeted and effective immune response against cancer cells.
These treatments are crucial for RCC patients as they offer targeted approaches to disrupt cancer growth and enhance immune system activity, potentially leading to better outcomes.
Non-clear cell renal cell carcinomas: biological insights and therapeutic challenges and opportunities.Novel immunotherapeutic strategies in development for renal cell carcinoma.
Non-clear cell renal cell carcinomas: biological insights and therapeutic challenges and opportunities.Novel immunotherapeutic strategies in development for renal cell carcinoma.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans and has grown in previously treated areas.I am fully active or can carry out light work.I have another cancer that is getting worse or was treated in the last 2 years.My kidney cancer has returned and worsened despite treatment.I have an autoimmune disease but it's either vitiligo, type 1 diabetes, manageable thyroid issues, skin conditions not needing systemic treatment, or arthritis treated without strong medication.I haven't taken cancer drugs within a period before starting the study treatment.I have a tumor sample available for testing.I still have major side effects from past cancer treatments.You have had a serious allergic reaction to monoclonal antibody therapy in the past.I haven't had a serious infection needing IV drugs in the last 2 weeks.You have taken a medication that is being tested and not yet approved.I have stable brain metastases after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation and Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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