A PHASE 1, DOSE-ESCALATION AND EXPANSION TRIAL OF PT2977, A HIF-2á INHIBITOR, IN PATIENTS WITH ADVANCED SOLID TUMORS

NOT ENROLLING
Protocol # :
17-634
Conditions
Advanced Solid Tumors
Solid Tumor
Solid Carcinoma
Solid Tumor, Adult
ccRCC
RCC, Clear Cell Adenocarcinoma
RCC
Kidney Cancer
Clear Cell Renal Cell Carcinoma
Renal Cell Carcinoma, Metastatic
Renal Cell Carcinoma Recurrent
Renal Cell Carcinoma, Clear Cell Adenocarcinoma
Glioblastoma
Glioblastoma, Adult
GBM
Glioblastoma Multiforme
Phase
I
Disease Sites
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
McDermott, David, F
Site Investigator
Choueiri, Toni, K.
Michaelson, M., Dror
Site Research Nurses
Cash, Hanna, Marie
Gotthardt, Susan, Jean
Gundy, Kathryn, E.
Gurski, Carol
Leisner, Claire
Markt, Denise, A.
Marujo, Rose
Pace, Amanda
Polinski, Karen
Porter, Kathryn
Prisby, Judith
Walsh, Meghara

Trial Description

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

Eligibility Requirements

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

17-634