A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prelude Therapeutics

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