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Relapsed/Refractory Advanced Solid TumorsPhase 1NCT03886831

A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

A Phase 1 study testing PRT543 in people with Relapsed/Refractory Advanced Solid Tumors and Relapsed/Refractory Diffuse Large B-cell Lymphoma, run by Prelude Therapeutics Incorporated at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers 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 PRT543. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PRT543
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
23 sitesUnited States
Study dates
11 Feb 2019to 16 Nov 2022
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

  • Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to established therapies
  • Biomarker-selected solid tumors
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Female patients 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

  • Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases
  • Requirement of pharmacologic doses of glucocorticoids
  • Prior treatment with chimeric antigen receptor T cells (CAR-T cells)
  • HIV positive; known active hepatitis B or C
  • Known hypersensitivity to any of the components of PRT543
  • Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less than 100 days since transplantation

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • The Ohio State University and Wexner Medical Center

    Columbus, Ohio, 43210

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Florida Cancer Specialists

    Lake Mary, Florida, 32746

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207

  • Atlantic Health System / Morristown Medical Center

    Morristown, New Jersey, 07962

  • PLLC

    Nashville, Tennessee, 37203

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health Services, Christiana Hospital

    Newark, Delaware, 19718

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UCSF Precision Cancer Medicine Building

    San Francisco, California, 94158

  • Florida Cancer Specialist

    Sarasota, Florida, 34232

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies

This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers 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 PRT543.

Read the detailed description

This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). The study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion part involving up to ten separate cohorts. For patients, 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 PRT543.

Being tested
PRT543
Keywords
PRMT5, PRMT5 Inhibitor
Medical subject headings
Recurrence, Lymphoma, Large B-Cell, Diffuse, Anemia, Refractory, with Excess of Blasts, Primary Myelofibrosis, Carcinoma, Adenoid Cystic, Lymphoma, Mantle-Cell, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRT543Drug

    PRT543 will be administered orally

Study groups in NCT03886831
Study groupRoleWhat they receive
PRT543ExperimentalPRT543 will be administered orally
Receives: Drug: PRT543

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To describe dose limiting toxicities (DLT) of PRT543

    Dose limiting toxicities (DLTs) will be evaluated during the first cycle

    Measured: Baseline through Day 28.

  2. To determine the maximally tolerated dose (MTD)

    The maximum tolerated dose (MTD) will be established for further investigation in participants with advanced malignancies who have failed prior treatments.

    Measured: Baseline through approximately 2 years.

  3. To determine the recommended phase 2 dose (RP2D) and schedule of PRT543

    The recommended phase 2 dose (RP2D) and optimal dosing schedule of PRT543 will be established for further investigation in participants with advanced malignancies who have failed prior treatments.

    Measured: Baseline through approximately 2 years.

Secondary outcomes (3)

  1. To describe the adverse event profile and tolerability of PRT543

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

    Measured: Baseline through approximately 2 years

  2. To determine the maximum observed plasma concentration (Cmax) of PRT543

    PRT543 pharmacokinetics will be calculated including the maximum observed plasma concentration.

    Measured: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.

  3. To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543

    PRT543 pharmacokinetics will be calculated including the time to reach maximum observed plasma concentration

    Measured: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: predose and 0.5, 1, 2, 4, 8, 24 hours postdose; predose on Cycle 1, Days 3, 4, 8, 11, and/or 22. Subsequently for Cycle 2 and beyond (until end of study treatment) on Day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start11 Feb 2019
  3. Primary completion16 Nov 2022
  4. Study completion16 Nov 2022

Resources

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
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03886831
Sponsor's protocol ID
PRT543-01
Status last verified
Mar 2023
First submitted
8 Mar 2019
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Maron MI, Abdel-Wahab O. Outstanding Questions to Understand and Target Splicing Factor-Mutant Blood Cancers. Blood Cancer Discov. 2026 May 5;7(3):348-352. doi: 10.1158/2643-3230.BCD-26-0047.

    PubMed 42013378

  • Ferrarotto R, Swiecicki PL, Zandberg DP, Baiocchi RA, Wesolowski R, Rodriguez CP, McKean M, Kang H, Monga V, Nath R, Palmisiano N, Babbar N, Sun W, Hanna GJ. PRT543, a protein arginine methyltransferase 5 inhibitor, in patients with advanced adenoid cystic carcinoma: An open-label, phase I dose-expansion study. Oral Oncol. 2024 Feb;149:106634. doi: 10.1016/j.oraloncology.2023.106634. Epub 2023 Dec 20.

    PubMed 38118249

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRT543 in people with Relapsed/Refractory Advanced Solid Tumors and Relapsed/Refractory Diffuse Large B-cell Lymphoma, run by Prelude Therapeutics Incorporated at 23 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 5 inclusion and 6 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 PRT543 (time frame: Baseline through Day 28.). 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 NCT03886831, which also lists 2 linked publications.

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 28 Mar 2023.

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