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NCT Number: NCT03886831

A Study of PRT543 in Participants 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.

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Key information

Conditions

Relapsed/Refractory Advanced Solid Tumors Adenocarcinoma Adenoid Cystic Carcinoma Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Carcinoma Carcinoma, Adenoid Cystic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Myelofibrosis Recurrence Refractory Chronic Myelomonocytic Leukemia Relapsed/Refractory Acute Myeloid Leukemia Relapsed/Refractory Diffuse Large B-cell Lymphoma Relapsed/Refractory Mantle Cell Lymphoma Relapsed/Refractory Myelodysplasia Relapsed/Refractory Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PRT543

Drug

PRT543 will be administered orally

Primary outcomes

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

    Time frame: Baseline through Day 28.

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

  2. To determine the maximally tolerated dose (MTD)

    Time frame: Baseline through approximately 2 years.

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

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

    Time frame: Baseline through approximately 2 years.

    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.

Secondary outcomes

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

    Time frame: Baseline through approximately 2 years

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

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

    Time frame: 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.

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

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

    Time frame: 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.

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

Other outcomes

  1. To determine the terminal elimination half-life (t1/2) of PRT543.

    Time frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: 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.

    PRT543 pharmacokinetics will be calculated including the terminal elimination half life

  2. To determine the area under the plasma concentration versus time curve (AUC) of PRT543

    Time frame: Cycle 1 (each cycle is 28 days) on Days 1, 15, and/or 25: 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.

    PRT543 pharmacokinetics will be calculated including area under the plasma concentration versus time curve.

Sponsors and collaborators

Lead sponsor

Prelude Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2019
Registry last updated
Mar 28, 2023

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

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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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