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Trial record 1 of 2 for:    PRT2527
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A Study of PRT2527 in Participants With Relapsed/Refractory Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT05665530
Recruitment Status : Recruiting
First Posted : December 27, 2022
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Prelude Therapeutics

Study Description
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Brief Summary:
This is a Phase 1 dose-escalation study of PRT2527, a potent and highly selective cyclin-dependent kinase (CDK) 9 inhibitor, in participants with select relapsed or refractory (R/R) hematologic malignancies. The purpose of this study is to evaluate the safety, tolerability, recommended phase 2 dose (PR2D), and preliminary efficacy of PRT2527.

Condition or disease Intervention/treatment Phase
Aggressive B-Cell Non-Hodgkin's Lymphoma Aggressive B-Cell NHL Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Mantle Cell Lymphoma (MCL) Richter's Syndrome Drug: PRT2527 Phase 1

Detailed Description:
This is an open-label, multi-center, dose-escalation, Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating participants with select R/R hematologic malignancies including aggressive B-cell lymphoma subtypes, mantle cell lymphoma (MCL), and chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL), including Richter's syndrome. The study will be conducted in two parts, the dose escalation phase and the dose confirmation phase. The dose escalation phase will evaluate escalating doses of PRT2527 until MTD is identified or when the RP2D is determined. The dose confirmation phase will evaluate indication-specific cohorts at the RP2D to confirm the dose. Approximately 51 participants will be enrolled in the dose escalation and indication-specific, dose confirmation cohorts.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 in Participants With Relapsed/Refractory Hematologic Malignancies
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRT2527
PRT2527 will be administered by intravenous infusion once weekly on a 21-day treatment cycle at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication-specific cohorts during the dose confirmation phase.
 Drug: PRT2527
PRT2527 will be administered by intravenous infusion once weekly on a 21-day treatment cycle


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) of PRT2527 [ Time Frame: Baseline through Day 21 ]
    Dose limiting toxicities will be evaluated over the 21-day observation period

  2. Safety and tolerability of PRT2527: AEs, CTCAE Assessments [ Time Frame: Baseline through approximately 2 years ]
    Safety and tolerability will be evaluated by incidence of DLTs, dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  3. Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT2527 [ Time Frame: Baseline through approximately 2 years ]
    The MTD/RP2D will be established for further investigation in participants with relapsed or refractory hematologic malignancies


Secondary Outcome Measures :
  1. Anti-tumor activity of PRT2527: Objective response rate (ORR) [ Time Frame: Baseline through approximately 2 years ]
    Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator in accordance with standard disease-specific criteria for the hematologic malignancies under study

  2. Anti-tumor activity of PRT2527: Duration of response/Complete Response (DOR/DoCR) [ Time Frame: Baseline through approximately 2 years ]
    Duration from time of first observed response (CR or PR) to the earliest date of disease progression, as assessed by the investigator in accordance with standard disease-specific criteria for the hematologic malignancies under study, or death due to any cause, whichever occurs first

  3. Pharmacokinetic profile of PRT2527: Maximum observed plasma concentration [ Time Frame: Baseline through approximately 2 years ]
    PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration (Cmax)

  4. Pharmacokinetic profile of PRT2527: Area under the curve [ Time Frame: Baseline through approximately 2 years ]
    PRT2527 pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)

  5. Pharmacokinetic profile of PRT2527: Time of maximum concentration [ Time Frame: Baseline through approximately 2 years ]
    PRT2527 pharmacokinetics will be calculated including the time of maximum concentration (Tmax)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  • Histologically or cytologically confirmed diagnosis of aggressive B-cell lymphoma subtypes, MCL or CLL/SLL, including Richter's syndrome, based on local testing that have relapsed or become refractory to or be ineligible for standard-of-care therapy
  • Must provide either an archival or fresh tumor tissue sample from a core or excisional/surgical biopsy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function (hematology, renal, and hepatic)
  • Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular ejection fraction of ≥ 50%

Exclusion Criteria:

  • Have active central nervous system involvement by malignancy, uncontrolled intercurrent illnesses, and active infections requiring systemic therapy
  • Have undergone HSCT within the last 90 days or have graft versus host disease (GvHD) Grade > 1 at study entry
  • Mean corrected QT interval of > 470 msec following triplicate ECG measurements or a history of long QT Syndrome
  • Have severe pulmonary disease with hypoxemia
  • History of another malignancy except for adequately treated non-melanoma skin cancer or lentigo maligna, superficial bladder cancer, and carcinoma in situ of the cervix without evidence of disease, and asymptomatic prostate cancer without known metastatic disease and no requirement for therapy
  • Concurrent treatment with strong CYP3A4 inhibitors or inducers
  • Prior exposure to a CDK9 inhibitor
  • Wait at least 5 half-lives of the agent or 14 days after their investigational or approved therapies before start of study treatment, whichever is shorter
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05665530


Contacts
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Contact: Study Contact (Please Do Not Disclose Personal Information) See Email PRT2527-02IVStudy@preludetx.com

Locations
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United States, Maryland
American Oncology Partners of Maryland, PA Recruiting
Bethesda, Maryland, United States, 20817
Sponsors and Collaborators
Prelude Therapeutics
More Information
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Responsible Party: Prelude Therapeutics
ClinicalTrials.gov Identifier: NCT05665530    
Other Study ID Numbers: PRT2527-02
First Posted: December 27, 2022    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prelude Therapeutics:
PRT2527
Aggressive B-Cell Non-Hodgkin's Lymphoma
Aggressive B-Cell NHL
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
CDK9
CLL/SLL
 Cyclin-Dependent Kinase 9
Hematologic Malignancies
Mantle Cell Lymphoma (MCL)
Relapse/Refractory
Richter's Syndrome
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Hematologic Neoplasms
Lymphoma, B-Cell
Aggression
Neoplasms by Histologic Type
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Leukemia
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Neoplasms by Site
Hematologic Diseases
Behavioral Symptoms