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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

ARC-20 Trial Summary

This trial studies an experimental drug for advanced solid tumors and ccRCC to evaluate safety, effects, and biomarkers.

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.Check my eligibility

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.See study design

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.

ARC-20 Trial 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.

ARC-20 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with adverse events (AEs)

Number of participants with dose limiting toxicities (DLTs)

Secondary outcome measures

Area under the plasma concentration time curve (AUC) of AB521

Maximum Observed Plasma Concentration (Cmax) of AB521

Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

+1 more

ARC-20 Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 3Experimental Treatment1 Intervention

Participants will receive AB521 orally

Group II: Dose Expansion Cohort 2Experimental Treatment1 Intervention

Participants will receive AB521 orally

Group III: Dose Expansion Cohort 1Experimental Treatment1 Intervention

Participants will receive AB521 orally

Group IV: Dose Escalation Cohort 4Experimental Treatment1 Intervention

Participants will receive AB521 orally

Group V: Dose Escalation Cohort 3Experimental Treatment1 Intervention

Participants will receive AB521 orally twice daily

Group VI: Dose Escalation Cohort 2Experimental Treatment1 Intervention

Participants will receive AB521 orally once daily

Group VII: Dose Escalation Cohort 1Experimental Treatment1 Intervention

Participants will receive AB521 orally once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AB521

2023

Completed Phase 1

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor

41 Previous Clinical Trials

5,920 Total Patients Enrolled

Medical DirectorStudy DirectorArcus Biosciences

2,777 Previous Clinical Trials

8,063,598 Total Patients Enrolled

Media Library

AB521 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05536141 — Phase 1

Renal Cell Carcinoma Research Study Groups: Dose Expansion Cohort 3, Dose Expansion Cohort 1, Dose Expansion Cohort 2, Dose Escalation Cohort 1, Dose Escalation Cohort 2, Dose Escalation Cohort 3, Dose Escalation Cohort 4

Renal Cell Carcinoma Clinical Trial 2023: AB521 Highlights & Side Effects. Trial Name: NCT05536141 — Phase 1

AB521 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536141 — Phase 1

Frequently Asked Questions

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

How many individuals are currently enrolled in this experiment?

"Indeed, data hosted on clinicaltrials.gov affirms that this medicinal trial is actively enrolling participants. This research was first posted on October 26th 2022 and the most recent update took place November 28th of the same year. As it stands, 86 individuals need to be recruited from a single site."

Answered by AI

Are individuals currently being recruited for participation in this research endeavor?

"Yes, the experiment is still open for recruitment. Clinicaltrials.gov states that it was initially published on October 26th 2022 and most recently updated on November 28th 2022."

Answered by AI

How risky is Cohort 3: Dose 3 for clinical trial participants?

"Given its Phase 1 status, our team at Power has assigned Cohort 3: Dose 3 a score of one on the safety scale due to a lack of clinical evidence for both efficacy and risk."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors

2022. "A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05536141.

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