New injection shows promise for tough kidney cancer
NCT ID NCT04169711
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called ARO-HIF2 in 26 people with advanced clear cell kidney cancer that had gotten worse after other treatments. The main goal was to find a safe dose and check for side effects. This is an early-phase trial, so it focuses on safety and dosing, not yet on curing the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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26 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Jul 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site 1
Aurora, Colorado, 80045, United States
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Research Site 2
Las Vegas, Nevada, 89169, United States
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Research Site 4
Nashville, Tennessee, 37232, United States
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Research Site 5
Dallas, Texas, 75390, United States
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Research Site 6
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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