A Study of PRT1419 in Patients With Advanced Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPRT1419

The study team can explain what participation involves.

Who it may be forSarcoma · Melanoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 15, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Prelude Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Prelude Therapeutics
Interventions being studied: Drug: PRT1419

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Sarah Cannon Research Institute at HealthONEDenver, Colorado
Florida Cancer SpecialistsLake Mary, Florida
Florida Cancer SpecialistsSarasota, Florida
University of Iowa Hospitals and ClinicsIowa City, Iowa
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania
UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 15, 2023. Always confirm current availability with the study team.

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