Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The primary objective of this study is to identify the maximum tolerated dose (MTD) of
belzutifan Tablets and/or the recommended Phase 2 dose (RP2D) of belzutifan Tablets in
patients with advanced solid tumors
Phase
Phase 1
Funding Agency/Sponsor
Industrial
Disease
Neurological Cancer
Enrollment Eligibility
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