RECRUITING

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

Conditions

Castrate Resistant Prostate Cancer NUT Carcinoma Chronic Myelomonocytic Leukemia Myelofibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-12-21

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05488548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Hemoglobin ≥ 9.0 g/dL (Part 1) * Absolute neutrophil count (ANC) ≥ 1,500/dL (Part 1) * Platelet count ≥100,000/μL (Part 1) or ≥75,000/μL (Part 3)	* 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 * Known history of hepatitis B, hepatitis C requiring antiviral treatment * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Inclusion Criteria

Exclusion Criteria

* 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.
* Hemoglobin ≥ 9.0 g/dL (Part 1)
* Absolute neutrophil count (ANC) ≥ 1,500/dL (Part 1)
* Platelet count ≥100,000/μL (Part 1) or ≥75,000/μL (Part 3)

* 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
* Known history of hepatitis B, hepatitis C requiring antiviral treatment
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Contacts and Locations

Study Contact

Judy Chiao, MD

CONTACT

(561) 865-6098

studies@epigenetix.com

Principal Investigator

Judy Chiao, MD

STUDY_DIRECTOR

Epigenetix, Inc.

Study Locations (Sites)

Mayo Clinic Arizona

Phoenix, Arizona, 85054

United States

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Mayo Clinic Rochester

Rochester, Minnesota, 55905

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Epigenetix, Inc.

Judy Chiao, MD, STUDY_DIRECTOR, Epigenetix, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-21

Study Completion Date2025-05

Study Record Updates

Study Start Date2022-12-21

Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

Castrate Resistant Prostate Cancer
NUT Carcinoma
Chronic Myelomonocytic Leukemia
Myelofibrosis