Homing in on a Moving Target: Androgen Receptor Cistromic Plasticity in Prostate Cancer.
Nils Eickhoff, Andries M Bergman, Wilbert Zwart
https://pubmed.ncbi.nlm.nih.gov/36125208Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05488548
Study of EP31670, a Dual BET and CBP/p300 Inhibitor, in Patients with Advanced Solid Tumors and Hematological Malignancies
Led by Epigenetix, Inc. · Updated on 2025-01-14
75
Participants Needed
6
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying EP31670, a new drug that targets proteins BET and CBP/p300, in patients with advanced solid tumors and certain blood cancers. This Phase 1, first-in-human trial focuses on patients with castration-resistant prostate cancer, NUT midline carcinoma, chronic myelomonocytic leukemia, myelofibrosis, and other similar conditions. The study aims to evaluate the safety and find the highest dose of EP31670 that patients can tolerate, as well as to recommend a dose for further studies. Participants will receive EP31670 orally, with the study using a dose-escalation design to determine the maximum tolerated dose. The trial involves multiple parts to include different patient groups based on their cancer type and prior treatments. Patients must have adequate organ function and meet specific health requirements to join. The study is open-label and conducted at multiple centers. During the study, participants will be closely monitored for side effects and treatment response over one treatment cycle (3 weeks) to identify dose-limiting toxicities and maximum tolerated dose. The recommended Phase 2 dose will be assessed throughout the study, which lasts about one year. Researchers will perform exams, lab tests, and imaging as needed to evaluate safety and effectiveness while ensuring patient health and wellbeing.
CONDITIONS
Official Title
Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Relapsed or refractory castration-resistant prostate cancer after at least one anti-androgen regimen and a docetaxel regimen OR metastatic or unresectable NUT midline carcinoma without standard curative or palliative options
- Relapsed or refractory chronic myelomonocytic leukemia after at least 4 cycles of hypomethylating agents or hydroxyurea unless disease progression or intolerance
- Advanced intermediate or high-risk myelofibrosis after at least one JAK inhibitor treatment or unsuitable for JAK inhibitors
- Advanced intermediate or high-risk myelofibrosis with 0% blasts in blood not responding or losing response after at least 3 months of JAK inhibitor therapy
- Other relapsed or refractory solid tumors or hematological malignancies with features suggesting benefit from dual BET and CBP/p300 inhibition with approval
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Evaluable disease
- Adequate bone marrow function (hemoglobin 5 9.0 g/dL, ANC 5 1,500/dL, platelet count 100,000/bcL or 75,000/bcL depending on study part)
- Adequate kidney function (creatinine clearance 5 60 mL/min)
- Adequate liver function (total bilirubin 4 1.5 x ULN; ALT or AST 4 2.5 x ULN or 4 5 x ULN if liver metastases)
- INR 4 1.2 in patients not on chronic anticoagulation
- At least 4 weeks since prior anti-cancer therapy or major surgery and recovered from related toxicities to grade 1 or less
- Agreement to use effective contraception during the study and 4 weeks after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- New or progressive central nervous system metastases; patients with treated brain metastases must have stable neurological status and no progression on imaging after 4 weeks
- Corrected QT interval of 470 msec or longer
- Uncontrolled illnesses such as active infections requiring IV antibiotics, symptomatic heart failure, unstable angina, cardiac arrhythmias, or psychiatric/social issues affecting compliance
- Pregnant or breastfeeding women
- Known hepatitis B or C requiring antiviral treatment
- HIV-infected patients not on effective antiretroviral therapy or with detectable viral load within 6 months
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 6 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
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Research Team
J
Judy Chiao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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