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A Study of PRT1419 in Patients With Advanced Solid Tumors

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: NCT04837677
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Prelude Therapeutics

Brief Summary:
This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

Condition or disease Intervention/treatment Phase
Sarcoma Melanoma Lung Cancer Breast Cancer Esophageal Cancer Cervical Cancer Head and Neck Cancer Drug: PRT1419 Phase 1

Detailed Description:
This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients with relapsed or refractory solid tumors, including breast, lung, sarcoma and melanoma as part of a 28-day treatment cycle. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 Study of PRT1419 in Patients With Advanced Solid Tumors
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: PRT1419
PRT1419 will be administered by intravenous infusion
Drug: PRT1419
PRT1419 will be administered by intravenous infusion




Primary Outcome Measures :
  1. Dose limiting toxicities (DLT) of PRT1419 [ Time Frame: Baseline through Day 28 ]
    Dose limiting toxicities will be evaluated through the first cycle

  2. Maximally tolerated dose (MTD) and/or optimal biological dose (OBD) [ Time Frame: Baseline through approximately 2 years ]
    The MTD and/or OBD will be established for further investigation in participants with advanced solid tumors.

  3. Recommended phase 2 dose (RP2D) and schedule of PRT1419 [ Time Frame: Baseline through approximately 2 years ]
    The RP2D will be established for further investigation in participants with advanced solid tumors.


Secondary Outcome Measures :
  1. Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments [ Time Frame: Baseline through approximately 2 years ]
    Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)

  2. Pharmacokinetic profile of PRT1419: maximum observed plasma concentration [ Time Frame: Baseline through approximately 2 years ]
    PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration

  3. Anti-tumor activity of PRT1419: measurement of objective responses [ Time Frame: Baseline through approximately 2 years ]
    Anti-tumor activity of PRT1419 will be based on the measurement of objective responses

  4. Progression-free survival [ Time Frame: Baseline through approximately 2 years ]
    Progression-free survival will be calculated from the first administration of PRT1419 until death or until the criteria for disease progression are met



Information from the National Library of Medicine

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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:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Left ventricular ejection fraction of ≥ 50%
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial
  • Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1)
  • All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 28 days, whichever is longer before study entry
  • Most recent lab values meet the following criteria:

    • Absolute neutrophil count > 1.0 x 10^3/μL;
    • Platelet count > 75,000/μL;
    • Hemoglobin > 9.0 g/dL
  • Histologically confirmed advanced or metastatic solid tumor indicated below that is relapsed, refractory, or intolerant to available therapies with known benefit:

    • Sarcoma not amendable to curative treatment with surgery or radiotherapy;
    • Melanoma (non-resectable or metastatic);
    • Small cell lung cancer (extensive-stage);
    • Non-small cell lung cancer;
    • Triple negative breast cancer (histopathologically or cytologically confirmed).
    • Esophageal cancer
    • Cervical cancer
    • Head and neck cancer

Exclusion Criteria:

  • Known hypersensitivity to any of the components of PRT1419
  • Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression
  • Female patients who are pregnant or lactating
  • Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
  • Mean QTcF interval of >480 msec
  • History of heart failure, additional risk factors for arrhythmias or requiring concomitant medications that prolong the QT/QTc interval
  • HIV positive; known active hepatitis B or C
  • Uncontrolled intercurrent illnesses
  • Treatment with strong inhibitors of CYP2C8
  • Prior exposure to an MCL1 inhibitor
  • History of another malignancy except:

    • Malignancy treated with curative intent with no known active disease for >2 years at study entry;
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
    • Adequately treated carcinoma in situ without evidence of disease;
    • Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor.

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): NCT04837677


Contacts
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Contact: Study Contact See Email PRT1419-02IVStudy@preludetx.com

Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists Recruiting
Lake Mary, Florida, United States, 32746
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Prelude Therapeutics
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Responsible Party: Prelude Therapeutics
ClinicalTrials.gov Identifier: NCT04837677    
Other Study ID Numbers: PRT1419-02
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022

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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:
MCL1