A Study of PRT1419 in Patients With Advanced Solid Tumors
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors
1 other identifier
interventional
26
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
August 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2023
CompletedMarch 15, 2023
March 1, 2023
1.5 years
April 5, 2021
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Dose limiting toxicities (DLT) of PRT1419
Dose limiting toxicities will be evaluated through the first cycle
Baseline through Day 28
Maximally tolerated dose (MTD) and/or optimal biological dose (OBD)
The MTD and/or OBD will be established for further investigation in participants with advanced solid tumors.
Baseline through approximately 2 years
Recommended phase 2 dose (RP2D) and schedule of PRT1419
The RP2D will be established for further investigation in participants with advanced solid tumors.
Baseline through approximately 2 years
Secondary Outcomes (4)
Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments
Baseline through approximately 2 years
Pharmacokinetic profile of PRT1419: maximum observed plasma concentration
Baseline through approximately 2 years
Anti-tumor activity of PRT1419: measurement of objective responses
Baseline through approximately 2 years
Progression-free survival
Baseline through approximately 2 years
Study Arms (1)
PRT1419
EXPERIMENTALPRT1419 will be administered by intravenous infusion
Interventions
Eligibility Criteria
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;
- +4 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Florida Cancer Specialists
Lake Mary, Florida, 32746, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
August 11, 2021
Primary Completion
February 6, 2023
Study Completion
February 6, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03