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

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Drug
  • PHASE1
  • Epigenetix, Inc.
  • 18 Years -


Study Purpose

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

Intervention

Drug : EP31670


Eligibility Requirements

info icon Part 1

info icon Relapse or refractory castration-resistant prostate cancer (CRPC) following at least one anti-androgen regimen and a docetaxel-containing regimen OR

info icon metastatic or unresectable NUT midline carcinoma for which standard curative or palliative measures do not exist; OR

info icon Part 2

info icon relapsed or refractory CMML following at least 4 cycles of hypomethylating agent-containing regimen or hydroxyurea unless demonstration of progression or intolerance;

info icon advanced MF (intermediate or high-risk) following at least one JAK inhibitor-containing regimen or unsuitable candidates for JAK inhibitor treatments.

info icon Part 3: advanced MF (intermediate or high-risk) with ≤10% blasts in peripheral blood who have not achieved an adequate response or have lost the response to a JAK inhibitor-containing regimen after being on treatment for at least 3 months.

info icon Patients who have other types of relapsed or refractory solid tumors (Part 1) or hematological malignancies (Part 2) with pathological and/or biological features suggesting a potential benefit from dual BET and CBP/p300 inhibition may be enrolled after discussion with and approval from medical monitor and sponsor.

info icon Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Life expectancy ≥ 3 months Evaluable disease

info icon Adequate bone marrow function:

info icon Hemoglobin ≥ 9.0 g/dL (Part 1)

info icon Absolute neutrophil count (ANC) ≥ 1,500/dL (Part 1)

info icon Platelet count ≥100,000/μL (Part 1) or ≥75,000/μL (Part 3)

info icon Adequate renal function: Creatinine clearance (CLcr) ≥ 60 mL/min

info icon Adequate liver function: total bilirubin ≤ 1.5 x ULN; alanine aminotransferase (ALT) or aspartate Aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases

info icon Internal normalized ratio for prothrombin time (INR) ≤ 1.2 in patients not receiving chronic anticoagulation

info icon Four weeks from prior anti-cancer therapy including chemotherapy, immunotherapy, investigational anti-cancer therapy or 5 half-lives from targeted agents, radiation and have recovered from prior treatment toxicities to grade 1 or less.

info icon Four weeks from major surgery.

info icon For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 4 weeks after the last dose of study drug.

info icon Ability to understand and willingness to sign the informed consent form.

info icon Minimum age: 18

info icon 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

info icon Corrected QT interval ≥470 msec

info icon 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

info icon Pregnant or lactating women

info icon Known history of hepatitis B, hepatitis C requiring antiviral treatment

info icon Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Recruiting status

Recruiting

Estimated enrollment

75

 
Study start date

Dec 21, 2022

Study end date

May 31, 2025

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1

Allocation

Non Randomized

 

Sponsor:

Epigenetix, Inc.

Collaborator:

N/A

Investigator:

Judy Chiao, MD

NCT05488548

Clinic Location Investigator Distance RECRUITING STATUS Contact