Phase
Condition
Carcinoma
Treatment
ARO-HIF2
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Research Site
Aurora, Colorado 80045
United StatesSite Not Available
Research Site 1
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Research Site
Las Vegas, Nevada 89169
United StatesSite Not Available
Research Site 2
Las Vegas 5506956, Nevada 5509151 89169
United StatesSite Not Available
Research Site
New York, New York 10016
United StatesSite Not Available
Research Site
Nashville, Tennessee 37232
United StatesSite Not Available
Research Site 4
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Research Site
Dallas, Texas 75390
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site 5
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available
Research Site 6
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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