A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)

• Status: Active, not recruiting
• Trial end date: 2023-04-14
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peloton Therapeutics, Inc.

Criteria

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