A Study of PRT1419 in Patients With Advanced Solid Tumors

NCT ID: NCT04837677

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2023-02-06

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.

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.

Conditions

Sarcoma; Melanoma; Lung Cancer; Breast Cancer; Esophageal Cancer; Cervical Cancer; Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRT1419

PRT1419 will be administered by intravenous infusion

Group Type: EXPERIMENTAL

PRT1419

Intervention Type: DRUG

PRT1419 will be administered by intravenous infusion

Interventions

PRT1419

PRT1419 will be administered by intravenous infusion

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prelude Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists

Lake Mary, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

PRT1419-02

Identifier Type: -

Identifier Source: org_study_id