NCT05488548

Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies

A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Epigenetix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor which has demonstrated antitumor activity in in vitro and in vivo models of human cancer. This Phase I open-label, multi-center, dose-escalation study will assess the safety and determine the maximum tolerated dose of EP31670 administered orally in patients with castration-resistant prostate cancer, NUT midline carcinoma and other targeted advanced solid tumors as well as chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other targeted hematological malignancies.

Conditions

• Castrate Resistant Prostate Cancer
• NUT Carcinoma
• Chronic Myelomonocytic Leukemia
• Myelofibrosis

Interventions

Type	Name	Description
DRUG	EP31670	EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor.

Timeline

• Start date: 2022-12-21
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2022-08-04
• Last updated: 2025-01-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study