Kidney Cancer Clinical Trial
Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
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 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
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.
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There are 5 Locations for this study
Aurora Colorado, 80045, United States
Las Vegas Nevada, 89169, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
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