Kidney Cancer Clinical Trial

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

Summary

The purpose of this study is to evaluate the safety and tolerability of AB521 when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Disease-specific criteria for dose escalation:
Participants may have any pathologically confirmed solid tumor type where no other treatment options are available.
Disease-specific criteria for dose-expansion:
Histologically confirmed ccRCC, must have received prior treatment in the metastatic setting (either individually or in combination) with an anti-programmed cell death protein 1 (anti-PD-1) therapy and a tyrosine kinase inhibitor (TKI), and no prior treatment with a hypoxia inducible factor (HIF)-2 alpha (α)-targeting therapy.
Must have at least one measurable lesion per RECIST guidance.
Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.

Key Exclusion Criteria:

Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
Underlying medical conditions that, in the investigator's judgment, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalizations with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs.
History of trauma or major surgery within 28 days prior to the first dose of investigational product.
For monotherapy dose expansion: prior treatment with an HIF-2α inhibitor.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

146

Study ID:

NCT05536141

Recruitment Status:

Recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 15 Locations for this study

See Locations Near You

UCLA
Santa Monica California, 90404, United States
University of Miami
Miami Florida, 33136, United States
University of Louisville Brown Cancer Center
Louisville Kentucky, 40202, United States
Mid-Florida Hematology & Oncology Centers, PA
New Orleans Louisiana, 70121, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Center
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Nebraska Cancer Specialists - Oncology Hematology West PC
Omaha Nebraska, 68124, United States
Next Oncology Virginia
New York New York, 10029, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Sarah Cannon
Nashville Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37240, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio Texas, 78229, United States
Seoul National University Bundang Hospital
Seoul , 13620, Korea, Republic of
Samsung Medical Center
Seoul , 6351, Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Severance Hospital Cancer Center
Seoul , , Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

146

Study ID:

NCT05536141

Recruitment Status:

Recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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