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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05488548
Recruitment Status : Recruiting
First Posted : August 4, 2022
Last Update Posted : February 16, 2023
Sponsor:
Information provided by (Responsible Party):
Epigenetix, Inc.

Study Description
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Brief Summary:
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors.

Condition or disease Intervention/treatment Phase
Castrate Resistant Prostate Cancer NUT Carcinoma Drug: EP31670 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation/de-escalation will follow rules by employing the Bayesian optimal interval (BOIN) method.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors
Actual Study Start Date : December 21, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Patients will be assigned escalated dose according to BOIN design. The starting dose is 5 mg orally once a day for 7 consecutive days followed by 14 days of rest.
 Drug: EP31670
EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor.
Other Name: NEO2734


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Within 3 weeks (one cycle) of treatment ]
    MTD is the highest dose level at which ≤30% of patients experienced DLTs during cycle 1.

  2. Dose Limiting Toxicities (DLT) [ Time Frame: Within 3 weeks (one cycle) of treatment ]
    DLT is any of the following adverse events (AEs) that occur during cycle 1.

  3. Recommended Phase 2 Dose (RP2D) [ Time Frame: through study completion, an average of 1 year ]
    RP2D will be the MTD


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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
  • patients who have other types of relapsed or refractory solid tumors 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 Absolute neutrophil count (ANC) ≥ 1,500/dL Platelet count ≥100,000/μL

  • Adequate renal function:

Creatinine clearance (CLcr) estimated by Cockcroft-Gault Equation to be ≥ 60 mL/min. Estimated glomeruli filtration rate (eGRF) ≥ 60 mL/min may be used if provided by the testing laboratory

  • Adequate liver function

    • Total bilirubin ≤ 1.5 x ULN except in patients diagnosed with Gilbert's disease for which direct bilirubin must be ≤ 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. Prostate cancer patients may continue androgen-deprivation therapy by luteinizing hormone-releasing hormone (LHRH) agonists.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05488548


Contacts
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Contact: Judy Chiao, MD (561) 865-6098 studies@epigenetix.com

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Atish Choudhury, MD    877-442-3324      
Contact: Jia Luo, MD    877-442-3324      
Principal Investigator: Atish Choudhury, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Rabia Khan    713-563-4667    RKhan@MDAnderson.org   
Principal Investigator: Sarina A Piha-Paul, MD         
United States, Washington
University of Washington/Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Contact: Chi Westerhold    206-606-7551    phase1clinicaltrial@seattlecca.org   
Principal Investigator: Michael Schweizer, MD         
Sponsors and Collaborators
Epigenetix, Inc.
Investigators
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Study Director: Judy Chiao, MD Epigenetix, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Epigenetix, Inc.
ClinicalTrials.gov Identifier: NCT05488548    
Other Study ID Numbers: EP31670-01
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases