Could a prostate cancer drug help fight kidney cancer?
NCT ID NCT06222593
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding bicalutamide (a prostate cancer drug) to sunitinib (a standard kidney cancer drug) can help people whose kidney cancer has stopped responding to other targeted therapies. The trial will enroll 28 adults with advanced renal cell carcinoma. Researchers will check for side effects and measure if tumors shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bicalutamide and sunitinib
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced kidney cancer that no longer responds to standard targeted therapy.
- What could go wrong
- This is an early-phase trial with only 28 participants, so results may not apply to everyone. The combination may cause side effects or fail to shrink tumors.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be greater than or equal to 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1 4. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale 5. Demonstrate adequate organ function 6. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. 7. Subjects of childbearing potential should be willing to use 2 methods of contraception for the course of the study through 120 days after the last dose of study medication 8. Male subjects without a previous vasectomy should agree to use an adequate method of contraception (i.e. abstinence, condom with spermicidal foam/gel/film/cream) starting with the first dose of study therapy through 120 days after the last dose of study therapy. 9. Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment. 10. Subjects must have a life expectancy of at least 6 months. Exclusion Criteria: 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has active Bacillus tuberculosis (TB) 4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 6. Has an active infection requiring systemic therapy. 7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 9. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 10. Has a known history of Human Immunodeficiency Virus (HIV) 11. Has known active Hepatitis B or Hepatitis C 12. Has received a live vaccine within 30 days of planned start of study therapy
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UB/ Great Lakes Cancer Care
RECRUITINGBuffalo, New York, 14203, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- A simple blood draw may spot kidney cancer early
- Personalized vaccine trains immune system to attack kidney cancer blood vessels
- New kidney cancer drug shows promise in early trial
- New hope for advanced kidney cancer: belzutifan takes on everolimus in major trial
- New hope for advanced kidney cancer: Triple-Drug combo shows promise