Overview

This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options including solid tumors, CNS lymphoma, and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors, CNS lymphoma, and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811.

Principal investigator

Varun Monga
Internal Medicine

Eligibility criteria

Inclusion Criteria:

  • Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies
  • Subjects must have recovered from the effects of any prior investigational system therapies
  • For subjects with lymphoma with CNS involvement: must have relapsed or refractory CNS lymphoma, adequate bone marrow reserves and at least one lesion measurable for response using the appropriate response criteria for the type of lymphoma.
  • For subjects with recurrent high-grade glioma or GBM, must have biopsy proven evidence (WHO Grade III or IV) and received external bean fractionated radiotherapy and at least 2 cycles of adjuvant temozolomide chemotherapy. Mutant Glioma must comply with biomarker defined enrollment criterias.
  • For biomarker-selected solid tumors: must meet enrollment criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Female subjects of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial

Exclusion Criteria:

  • Untreated concurrent malignancies or malignancies that have been in complete remission for less than one year
  • Treatment with strong inhibitors of CYP3A4 for which there are no therapeutic substitutions
  • Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
  • HIV positive; known active hepatitis B or C
  • Known hypersensitivity to any of the components of PRT811
Show more

Participate in this trial

Are you interested in enrolling in this study? Learn more here.

I'm Interested In Participating

For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Alyssa Pratt
Enroll your patient