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NCT Number: NCT04089449

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

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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Key information

Conditions

Advanced Solid Tumor Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Recurrent Glioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRT811

Drug

PRT811 will be administered orally

Primary outcomes

  1. To describe dose limiting toxicities (DLT) of PRT811

    Time frame: Baseline through Day 21

    Dose limiting toxicities will be evaluated through the first cycle

  2. To determine the maximally tolerated dose (MTD)

    Time frame: Baseline through approximately 2 years

    The MTD will be established for further investigation in participants with solid tumors and gliomas

  3. To determine the recommended phase 2 dose (RP2D) and schedule of PRT811

    Time frame: Baseline through approximately 2 years

    The RP2D will be established for further investigation in participants with solid tumors and gliomas

Secondary outcomes

  1. To describe the adverse event profile and tolerability of PRT811

    Time frame: Baseline through approximately 2 years

    Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy

  2. To describe the pharmacokinetic profile of PRT811

    Time frame: Cycle 1 (each cycle is 21 days) on Days 1, 8 and 14. For subsequent cycles, Day 1 of each cycle through the end of study treatment, an average of 6 months

    PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration

  3. To describe any anti-tumor activity of PRT811

    Time frame: Baseline through approximately 2 years

    Anti-tumor activity of PRT811 will be based on the measurement of objective responses

Sponsors and collaborators

Lead sponsor

Prelude Therapeutics

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2019
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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