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Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma

A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma

NCT04169711•Arrowhead Pharmaceuticals

Summary

The purpose of this study is to evaluate the safety and efficacy of ARO-HIF2 injection (also referred to as ARO-HIF2) and to determine the recommended Phase 2 dose in the treatment of patients with advanced clear cell renal cell carcinoma (ccRCC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
•Willing to provide written informed consent and to comply with study requirements
•Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma that has progressed during or after at least two prior therapeutic regimens which must include vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor therapy or that has otherwise failed such therapies, is measurable disease per RECIST 1.1 criteria, is biopsy accessible
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
•Estimated life expectancy of longer than 3 months
•Adequate organ function at screening

Exclusion Criteria

•History of untreated brain metastasis or leptomeningeal disease or spinal cord compression
•Failure to recover from reversible effects of prior anti-cancer therapy
•Has received systemic therapy or radiation therapy within 2 weeks prior to first dose
•History of solid organ or stem cell transplantation
•Current use of anti-VEGF or mammalian target of rapamycin (mTOR) agents, or chronic immunosuppressive therapy
•Any prior use of hypoxia inducible factor 2 (HIF2) inhibitors within 6 months prior to first dose
•Current use of immune checkpoint inhibitors
•Use of an investigational agent or device within 2 weeks prior to dosing, or current participation in an investigational study
•Known HIV, hepatitis B or hepatitis C
•History of other clinically meaningful disease
+3 more criteria

Locations (5)

Research Site 1

Aurora, Colorado, United States

Research Site 2

Las Vegas, Nevada, United States

Research Site 4

Nashville, Tennessee, United States

Research Site 5

Dallas, Texas, United States

Research Site 6

Houston, Texas, United States

Key Dates

Start Date

August 17, 2020

Primary Completion Date

January 24, 2022

Completion Date

July 22, 2022

Last Updated

October 9, 2025

Enrollment

ACTUAL participants

Conditions

Clear Cell Renal Cell Carcinoma

Interventions

ARO-HIF2

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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