A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04089449 |
Recruitment Status :
Recruiting
First Posted : September 13, 2019
Last Update Posted : August 1, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor Recurrent Glioma CNS Lymphoma | Drug: PRT811 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 145 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | November 6, 2019 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: PRT811
PRT811 will be administered orally
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Drug: PRT811
PRT811 will be administered orally |
- To describe dose limiting toxicities (DLT) of PRT811 [ Time Frame: Baseline through Day 21 ]Dose limiting toxicities will be evaluated through the first cycle
- 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
- 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
- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089449
Contact: Study Contact | 615-329-7274 | CANN.REFMAL655@SarahCannon.com |
United States, Colorado | |
Sarah Cannon Research Institute at HealthONE | Recruiting |
Denver, Colorado, United States, 80218 | |
United States, Connecticut | |
Yale- New Haven Hospital- Yale Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06510 | |
United States, Delaware | |
Christiana Care Health Services, Christiana Hospital | Recruiting |
Newark, Delaware, United States, 19718 | |
United States, Florida | |
Florida Cancer Specialists | Recruiting |
Lake Mary, Florida, United States, 32746 | |
United States, Georgia | |
Georgia Cancer Center at Augusta University | Recruiting |
Augusta, Georgia, United States, 30912 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 | |
United States, Missouri | |
Washington University School of Medicine - Siteman Cancer Center | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
The Ohio State University and Wexner Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Thomas Jefferson University, Sidney Kimmel Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Tennessee Oncology | Recruiting |
Nashville, Tennessee, United States, 37203 |
Responsible Party: | Prelude Therapeutics |
ClinicalTrials.gov Identifier: | NCT04089449 |
Other Study ID Numbers: |
PRT811-01 |
First Posted: | September 13, 2019 Key Record Dates |
Last Update Posted: | August 1, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PRMT5 PRMT5 Inhibitor |
Lymphoma Glioma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |