What side effects are associated with this type of intervention?

Common treatments for Renal Cell Carcinoma (RCC), particularly those similar to AB521, often include targeted therapies and antiangiogenic agents. These treatments can have a range of side effects. For example, antiangiogenic agents have been associated with adverse events such as hypertension, proteinuria, and fatigue. Other targeted therapies may cause neutropenia, diarrhea, and hand-foot syndrome. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for Renal Cell Carcinoma (RCC) include several immunotherapy and targeted therapy agents. Notable approvals include nivolumab and pembrolizumab, which are PD-1 checkpoint inhibitors, and avelumab and atezolizumab, which are PD-L1 checkpoint inhibitors. Additionally, combinations such as nivolumab plus ipilimumab (a CTLA-4 inhibitor) and avelumab plus axitinib (a VEGF inhibitor) have been approved. These treatments are similar to AB521 in that they target advanced stages of RCC and aim to modulate the immune response or inhibit specific pathways involved in tumor growth.

What other types of research exist?

Promising novel alternatives to AB521 for Renal Cell Carcinoma patients include: 1) Nivolumab plus Ipilimumab, which has shown superior efficacy and manageable safety in the CheckMate 214 trial for advanced RCC. 2) Pembrolizumab, which has demonstrated improved disease-free survival in the KEYNOTE-564 trial as adjuvant therapy post-nephrectomy. 3) Lenvatinib plus Pembrolizumab, which has shown positive outcomes in both treatment-naive and previously treated metastatic RCC patients in the KEYNOTE-146 study.

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CAR T-cell Therapy

AB521 for Renal Cell Carcinoma (ARC-20 Trial)

Phase 1

Recruiting

Research Sponsored by Arcus Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1

Histologically confirmed ccRCC, must have received prior treatment in the metastatic setting with an anti-PD-1 therapy and a TKI, and no prior treatment with a HIF-2α-targeting therapy

Must not have

For monotherapy dose expansion: prior treatment with an HIF-2α inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug called AB521 to see if it is safe for people with advanced cancers, including a type of kidney cancer called clear cell renal cell carcinoma. In some parts of the study, AB521 will be used alone, and in others, it will be combined with another drug called cabozantinib, which stops cancer cells from growing.

Who is the study for?

This trial is for adults with advanced solid tumors or clear cell renal cell carcinoma (ccRCC) who have tried other treatments without success. They must have had prior anti-PD-1 therapy and a TKI, no HIF-2α-targeting therapy, at least one measurable tumor lesion, and be in good physical condition with an ECOG score of ≤ 1.

What is being tested?

The study tests the safety and tolerability of AB521 as a solo treatment for patients with various advanced solid tumors including ccRCC. It aims to find out how well participants handle this new drug and what effects it has on their cancer.

What are the potential side effects?

While specific side effects are not listed, common ones may include fatigue, nausea, skin reactions at the injection site, allergic reactions to the drug components, or potential worsening of underlying health conditions.

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 have some restrictions but can still care for myself.

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I have kidney cancer, treated with specific drugs but not HIF-2α inhibitors.

Exclusion Criteria

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

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I have previously been treated with an HIF-2α inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

9Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 4Experimental Treatment2 Interventions

Participants will receive AB521 orally with Cabozantinib

Group II: Dose Expansion Cohort 3Experimental Treatment1 Intervention