Status:
COMPLETED
A Study of PRT1419 in Patients With Advanced Solid Tumors
Lead Sponsor:
Prelude Therapeutics
Conditions:
Sarcoma
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, maxi...
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 melanom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04837677
Start Date
August 11 2021
End Date
February 6 2023
Last Update
March 15 2023
Active Locations (7)
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1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
2
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242