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NCT05536141 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumors and Clear Cell Renal Cell Carcinoma, sponsored by Arcus Biosciences.

Recruiting
Registry status
Phase 1
Development phase
362
Enrollment target
20
Study locations

NCT05536141 is a Phase 1 study of Solid Tumors and Clear Cell Renal Cell Carcinoma that is actively recruiting participants, run by Arcus Biosciences. The registered enrollment target is 362 participants, above the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT05536141, a Phase 1 study of Solid Tumors and Clear Cell Renal Cell Carcinoma, is actively recruiting participants, sponsored by Arcus Biosciences.

RECRUITING
Registry status
Phase 1
Development phase
362 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Conditions Studied

Solid Tumors Clear Cell Renal Cell Carcinoma

Interventions

  • DRUG Ipilimumab
  • DRUG Zimberelimab
  • DRUG Cabozantinib
  • DRUG casdatifan

Study Locations (20)

California

  • University of California at San Diego - San Diego
  • UCLA - Santa Monica

Michigan

  • Barbara Ann Karmanos Cancer Center - Detroit
  • Henry Ford Health System - Detroit

New York

  • Tisch Cancer Institute, Icahn Mount Sinai Hospital - New York
  • Memorial Sloan Kettering - New York

Ohio

  • University Hospitals Cleveland Clinical - Cleveland
  • Cleveland Clinic - Cleveland

Tennessee

  • Sarah Cannon - Nashville
  • Vanderbilt-Ingram Cancer Center - Nashville

Alabama

  • University of Alabama at Birmingham - Birmingham

Florida

  • University of Miami - Miami

Georgia

  • Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2022-10-26
Est. Completion 2029-03
Phase Phase 1

Sponsor

Arcus Biosciences

25 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05536141

The ClinicalTrials.gov registry entry for NCT05536141 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target (28% higher). The listed sponsor is Arcus Biosciences, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 4 interventions - of which Ipilimumab is the first listed.

NCT05536141 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Michigan, New York.

Frequently Asked Questions

What is clinical trial NCT05536141 about?

NCT05536141 is a clinical study titled "A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors". The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with...

What is the current status of trial NCT05536141?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 362 participants. The study started on 2022-10-26. Estimated completion is 2029-03.

What conditions does trial NCT05536141 study?

This clinical trial studies the following conditions: Solid Tumors, Clear Cell Renal Cell Carcinoma.

What interventions are being tested in trial NCT05536141?

The interventions under investigation include: Ipilimumab (DRUG), Zimberelimab (DRUG), Cabozantinib (DRUG), casdatifan (DRUG).

Who is sponsoring clinical trial NCT05536141?

This trial is sponsored by Arcus Biosciences, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05536141 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.