A Study of PRT1419 in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Sarcoma, Melanoma, Lung Cancer, Breast Cancer, Esophageal Cancer, Cervical Cancer, Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT04837677
- Run by
- Prelude Therapeutics
- People needed
- 26
- Starts
- 2021-08-11
- Expected to finish
- 2023-02-06
- Last updated by the study team
- 2023-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.