Clinical Research Directory

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