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

Last updated: October 7, 2025
Sponsor: Arrowhead Pharmaceuticals
Overall Status: Completed

Phase

1

Condition

Carcinoma

Treatment

ARO-HIF2

Clinical Study ID

NCT04169711
AROHIF21001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women of childbearing potential must have a negative pregnancy test, cannot bebreastfeeding 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 cellcarcinoma that has progressed during or after at least two prior therapeuticregimens which must include vascular endothelial growth factor (VEGF)-targetedtherapy and checkpoint inhibitor therapy or that has otherwise failed suchtherapies, 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

Exclusion Criteria:

  • History of untreated brain metastasis or leptomeningeal disease or spinal cordcompression

  • Failure to recover from reversible effects of prior anti-cancer therapy

  • Has received systemic therapy or radiation therapy within 2 weeks prior to firstdose

  • History of solid organ or stem cell transplantation

  • Current use of anti-VEGF or mammalian target of rapamycin (mTOR) agents, or chronicimmunosuppressive therapy

  • Any prior use of hypoxia inducible factor 2 (HIF2) inhibitors within 6 months priorto first dose

  • Current use of immune checkpoint inhibitors

  • Use of an investigational agent or device within 2 weeks prior to dosing, or currentparticipation in an investigational study

  • Known HIV, hepatitis B or hepatitis C

  • History of other clinically meaningful disease

  • Major surgery within 4 weeks of Screening

  • Active malignancy requiring therapy other than ccRCC within 3 years of study entry

Note: Other eligibility criteria may apply per protocol.

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: ARO-HIF2
Phase: 1
Study Start date:
August 17, 2020
Estimated Completion Date:
July 22, 2022

Connect with a study center

  • Research Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Site 1

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Research Site 2

    Las Vegas 5506956, Nevada 5509151 89169
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Research Site 4

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site 5

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • Research Site 6

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.