To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT05488548

Condition: Castrate Resistant Prostate Cancer
NUT Carcinoma
Chronic Myelomonocytic Leukemia
Myelofibrosis

Conditions: Official terms:
Hematologic Neoplasms
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Intervention model description: Dose escalation/de-escalation will follow rules by employing the Bayesian optimal interval (BOIN) method for Part 1 and Part 2 and traditional 3+ 3 by modified Fibonacci sequence for Part 3

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: EP31670
Description: EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor.
Arm group label: Part 1
Arm group label: Part 2
Arm group label: Part 3

Other name: NEO2734

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Part 1 - 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 Part 2 - 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. 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. 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. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Life expectancy ≥ 3 months Evaluable disease Adequate bone marrow function: - 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) Adequate renal function: Creatinine clearance (CLcr) ≥ 60 mL/min 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 Internal normalized ratio for prothrombin time (INR) ≤ 1.2 in patients not receiving chronic anticoagulation 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. Four weeks from major surgery. 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. Ability to understand and willingness to sign the informed consent form. Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic Arizona

Address:
City: Phoenix
Zip: 85054
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015

Investigator:
Last name: Jeanne Palmer, MD
Email: Principal Investigator

Facility:
Name: Mayo Clinic Florida

Address:
City: Jacksonville
Zip: 32224
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015

Investigator:
Last name: James Foran, MD
Email: Principal Investigator

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Atish Choudhury, MD

Phone: 877-442-3324

Contact backup:
Last name: Jia Luo, MD

Phone: 877-442-3324

Investigator:
Last name: Atish Choudhury, MD
Email: Principal Investigator

Facility:
Name: Mayo Clinic Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015

Investigator:
Last name: Mrinal Patnaik, MD
Email: Principal Investigator

Facility:
Name: The University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Rabia Khan

Phone: 713-563-4667
Email: RKhan@MDAnderson.org

Investigator:
Last name: Sarina A Piha-Paul, MD
Email: Principal Investigator

Facility:
Name: University of Washington/Fred Hutchinson Cancer Center

Address:
City: Seattle
Zip: 98109
Country: United States

Status: Recruiting

Contact:
Last name: Sheila Pagtakhan
Email: phase1clinicaltrial@seattlecca.org

Investigator:
Last name: Michael Schweizer, MD
Email: Principal Investigator

Start date: December 21, 2022

Completion date: May 2025

Lead sponsor:
Agency: Epigenetix, Inc.
Agency class: Industry

Source: Epigenetix, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05488548

Login to your account

Did you forget your password?