Advanced Solid TumorPhase 1NCT04089449
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
A Phase 1 study testing PRT811 in people with Advanced Solid Tumor and Recurrent Glioma, run by Prelude Therapeutics Incorporated at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Recurrent Glioma
- What is being tested?
- PRT811
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Nov 2019to 28 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The Ohio State University and Wexner Medical Center
Columbus, Ohio, 43210
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Florida Cancer Specialists
Lake Mary, Florida, 32746
Tennessee Oncology
Nashville, Tennessee, 37203
Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, 19718
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
About this study
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
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor, Recurrent Glioma
- Being tested
- PRT811
- Keywords
- PRMT5, PRMT5 Inhibitor
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT811Drug
PRT811 will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| PRT811 | Experimental | PRT811 will be administered orally Receives: Drug: PRT811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe dose limiting toxicities (DLT) of PRT811
Dose limiting toxicities will be evaluated through the first cycle
Measured: Baseline through Day 21
To determine the maximally tolerated dose (MTD)
The MTD will be established for further investigation in participants with solid tumors and gliomas
Measured: Baseline through approximately 2 years
To determine the recommended phase 2 dose (RP2D) and schedule of PRT811
The RP2D will be established for further investigation in participants with solid tumors and gliomas
Measured: Baseline through approximately 2 years
Secondary outcomes (3)
To describe the adverse event profile and tolerability of PRT811
Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Measured: Baseline through approximately 2 years
To describe the pharmacokinetic profile of PRT811
PRT811 pharmacokinetics will be calculated including the maximum observed plasma concentration
Measured: 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
To describe any anti-tumor activity of PRT811
Anti-tumor activity of PRT811 will be based on the measurement of objective responses
Measured: Baseline through approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start6 Nov 2019
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prelude Therapeutics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089449
- Sponsor's protocol ID
- PRT811-01
- Status last verified
- Apr 2023
- First submitted
- 11 Sep 2019
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Barry A, Samuel SF, Hosni I, Moursi A, Feugere L, Sennett CJ, Deepak S, Achawal S, Rajaraman C, Iles A, Wollenberg Valero KC, Scott IS, Green V, Stead LF, Greenman J, Wade MA, Beltran-Alvarez P. Investigating the effects of arginine methylation inhibitors on microdissected brain tumour biopsies maintained in a miniaturised perfusion system. Lab Chip. 2023 May 30;23(11):2664-2682. doi: 10.1039/d3lc00204g.
PubMed 37191188
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04089449
- Acronym / sponsor ID
- PRT811-01
- Conditions
- Advanced Solid Tumor, Recurrent Glioma
- Keywords
- PRMT5, PRMT5 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Prelude Therapeutics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRT811 | Experimental | Drug: PRT811PRT811 will be administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRT811PRT811 will be administered orally | Drug | PRT811 |
Primary outcome
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
3 secondary outcomes
To describe the adverse event profile and tolerability of PRT811
Time frame: Baseline through approximately 2 years
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
To describe any anti-tumor activity of PRT811
Time frame: Baseline through approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 37191188Barry A, Samuel SF, Hosni I, Moursi A, Feugere L, Sennett CJ, Deepak S, Achawal S, Rajaraman C, Iles A, Wollenberg Valero KC, Scott IS, Green V, Stead LF, Greenman J, Wade MA, Beltran-Alvarez P. Investigating the effects of arginine methylation inhibitors on microdissected brain tumour biopsies maintained in a miniaturised perfusion system. Lab Chip. 2023 May 30;23(11):2664-2682. doi: 10.1039/d3lc00204g.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT811 in people with Advanced Solid Tumor and Recurrent Glioma, run by Prelude Therapeutics Incorporated at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe dose limiting toxicities (DLT) of PRT811 (time frame: Baseline through Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04089449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.