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

Prelude Therapeutics

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumor

Recurrent Glioma

Treatments

Drug: PRT811

Study type

Interventional

Funder types

Industry

Identifiers

NCT04089449

PRT811-01

Details and patient eligibility

About

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.

Full description

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, 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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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