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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2023-03-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Tumor Recurrent Glioma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRT811

PRT811 will be administered orally

Group Type EXPERIMENTAL

PRT811

Intervention Type DRUG

PRT811 will be administered orally

Interventions

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PRT811

PRT811 will be administered orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No