Actively Recruiting
Dual BET and CBP/p300 Inhibitor in Patients With Targeted 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
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
CONDITIONS
Official Title
Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
Who Can Participate
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
AI-Powered Screening
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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
Research Team
J
Judy Chiao, MD
CONTACT
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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