Can a pill that starves tumors of oxygen help fight advanced cancer?
NCT ID NCT02974738
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental drug called belzutifan in people with advanced solid tumors that have not responded to standard treatments. Belzutifan works by blocking a protein (HIF-2α) that tumors use to survive in low-oxygen conditions. The main goal is to find the safest dose and see how the body handles the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belzutifan (a HIF-2α inhibitor drug)
- What this could lead to
- If successful, this could lead to a new treatment option for advanced solid tumors, including kidney cancer and glioblastoma.
- What could go wrong
- This is an early phase 1 trial, so the drug may not work or could cause serious side effects. The goal is primarily to find a safe dose, not to prove effectiveness.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
120 people
The number who actually took part.
- Started
-
Dec 2016
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Has a diagnosis of locally advanced or metastatic solid tumor * Is of age ≥ 18 years * Has a life expectancy of ≥ 6 months * Has adequate organ function * If a female patient, must not be pregnant or breastfeeding and not a woman of childbearing potential (WOCBP) OR a WOCBP who uses contraception or is abstinent from heterosexual intercourse during the study and for a minimum of 30 days after the last study drug administration, or if a male patient, must be abstinent from heterosexual intercourse OR agree to use contraception * Able to swallow oral medications Additional Inclusion Criteria for GBM cohort * Must have histologically confirmed glioblastoma, IDH-wild type that is first recurrent following radiation therapy and temozolomide according to the Response Assessment in Neuro-Oncology (RANO) criteria * Must have archival tumor tissue available from a previous surgery for glioblastoma * Must have measurable (defined as at least 1 cm x 1 cm) contrast-enhancing lesion by MRI imaging within 21 days of starting treatment * Must be able to undergo MRI of the brain with gadolinium. Patients must be maintained on a stable or decreasing dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI * Must have recovered from prior therapy to grade ≤1 severity (except for alopecia and lymphocytopenia) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Exclusion Criteria: * Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression * Has failed to recover from the reversible effects of prior anticancer therapy (does not apply to GBM cohort) * Has uncontrolled or poorly controlled hypertension * Has malabsorption due to prior gastrointestinal (GI) surgery or GI disease * Has had any major cardiovascular event within 6 months prior to study drug administration * Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results * Has had major surgery within 4 weeks before first study drug administration * Has known HIV * Has an active infection requiring systemic treatment * Is participating in another therapeutic clinical trial Additional Excusion Criteria for GBM cohort: * Has received prior anti-VEGF therapy including bevacizumab (i.e. patients must be bevacizumab naïve) * Is receiving enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of belzutifan
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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.
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Other studies related to the condition(s) this trial covers.
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