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Study of EP31670 for Advanced Solid Tumors and Blood Cancers

This study is testing a new drug called EP31670 (also known as NEO2734) in people with certain advanced solid tumors and blood cancers. EP31670 is a first-of-its-kind drug that works by targeting specific pathways in cancer cells (dual BET and CBP/p300 inhibitor). The main goals of this study are to find the highest safe dose of EP31670, understand any side effects, and determine the recommended dose for future studies. You may be able to join if you have castration-resistant prostate cancer, NUT carcinoma, chronic myelomonocytic leukemia (CMML), or myelofibrosis that has not responded to previous treatments. About 75 people are expected to participate.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving EP31670. It is a dose-escalation study, which means participants will receive increasing doses of the drug to find the safest and most effective amount.
What's involved
The study will assess the maximum tolerated dose and dose-limiting toxicities within the first 3 weeks (one cycle) of treatment. The recommended Phase 2 dose will be determined through study completion, which is expected to be an average of 1 year.
Compensation
Not stated in the trial record.
Follow-up
The study will determine the recommended Phase 2 dose through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05488548

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Epigenetix, Inc.
~75 participants
Updated 2025-01-14 on ClinicalTrials.gov
What's tested:EP31670

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Within 3 weeks (one cycle) of treatment
+2 more outcomes measured

Conditions

Castrate Resistant Prostate Cancer
NUT Carcinoma
Chronic Myelomonocytic Leukemia
Myelofibrosis

Explore related trials

Chronic Myelomonocytic LeukemiaMyelofibrosisNUT CarcinomaProstate Carcinoma

Where it's being run

6 sites across 6 states
Arizona1
Florida1
Massachusetts1
Minnesota1
Texas1
Washington1

Study leadership

  • Judy Chiao, MD · STUDY_DIRECTOR · Epigenetix, Inc.

Who to contact

Judy Chiao, MD
[email protected]
(561) 865-6098
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Maximum Tolerated Dose (MTD)Within 3 weeks (one cycle) of treatment

    MTD is the highest dose level at which ≤30% of patients experienced DLTs during cycle 1.

  • Dose Limiting Toxicities (DLT)Within 3 weeks (one cycle) of treatment

    DLT is any of the following adverse events (AEs) that occur during cycle 1.

  • Recommended Phase 2 Dose (RP2D)through study completion, an average of 1 year

    RP2D will be the MTD