What side effects are associated with this type of intervention?

Common treatments for Renal Cell Carcinoma, such as immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab) and tyrosine kinase inhibitors (e.g., sunitinib, pazopanib), are associated with several side effects. Immune checkpoint inhibitors can cause immune-related adverse events, including fatigue, rash, diarrhea, and liver enzyme abnormalities. Severe toxicities may include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Tyrosine kinase inhibitors often lead to hypertension, hand-foot syndrome, diarrhea, fatigue, and hematologic abnormalities. Both classes of drugs require careful monitoring and management of side effects to ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for Renal Cell Carcinoma (RCC) that involve targeting tumor antigens and immune cells. Notably, immune checkpoint inhibitors like nivolumab and pembrolizumab have been approved for RCC. These drugs work by targeting PD-1/PD-L1 pathways to enhance the immune system's ability to fight cancer. Additionally, combinations such as nivolumab with ipilimumab (an anti-CTLA-4 antibody) have shown efficacy in RCC. While bispecific antibodies like XmAb®819 are still under investigation, these approved treatments share the common goal of leveraging the immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to XmAb®819 for Renal Cell Carcinoma patients in 2024 include: 1) Pembrolizumab combined with axitinib, which has shown efficacy in advanced RCC. 2) Nivolumab combined with ipilimumab, another immune checkpoint inhibitor combination with proven benefits in RCC. 3) Avelumab combined with axitinib, which targets PD-L1 and has demonstrated positive outcomes in clinical trials. These alternatives leverage immune checkpoint inhibition and targeted therapy, offering new hope for RCC patients.

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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

Must not have

Failure to recover from any clinically significant toxicity related to previous anticancer treatment

Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests XmAb®819, a new drug for kidney cancer patients whose disease has returned or resisted other treatments. It checks if the drug is safe, how the body handles it, and its potential to reduce tumors.

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have major side effects from past cancer treatments.

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I haven't had a serious infection needing IV drugs in the last 2 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (DLTs)

Therapeutic procedure

Secondary study objectives

Duration of response

Measurement of AUCtau

Measurement of Cmax

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met

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.