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
Relapse or refractory castration-resistant prostate cancer (CRPC) following at least one anti-androgen regimen and a docetaxel-containing regimen OR
metastatic or unresectable NUT midline carcinoma for which standard curative or palliative measures do not exist; OR
relapsed or refractory CMML following at least 4 cycles of hypomethylating agent-containing regimen or hydroxyurea unless demonstration of progression or intolerance;
advanced MF (intermediate or high-risk) following at least one JAK inhibitor-containing regimen or unsuitable candidates for JAK inhibitor treatments.
New and progressive central nervous system (CNS) metastasis; patients with treated brain metastases are eligible if follow-up brain imaging at least 4 weeks after CNS-directed therapy shows no evidence of progression and the patient is neurologically stable
Corrected QT interval ≥470 msec
Uncontrolled concurrent illnesses including, but not limited to, ongoing active infection requiring intravenous antibiotics or antifungal agents, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would affect compliance with study requirements; patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of EP31670 are eligible for this trial
Pregnant or lactating women
Single group
EP31670
DrugEP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor.
Maximum Tolerated Dose (MTD)
MTD is the highest dose level at which ≤30% of patients experienced DLTs during cycle 1.
Dose Limiting Toxicities (DLT)
DLT is any of the following adverse events (AEs) that occur during cycle 1.
Recommended Phase 2 Dose (RP2D)
RP2D will be the MTD
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