NCT05488548 Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
| NCT ID | NCT05488548 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Epigenetix, Inc. |
| Condition | Castrate Resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2022-12-21 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 75 participants in total. It began in 2022-12-21 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 and Hematological Malignancies
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
Contact & Investigator
Judy Chiao, MD
STUDY DIRECTOR
Epigenetix, Inc.
Frequently Asked Questions
Who can join the NCT05488548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Castrate Resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05488548 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05488548 currently recruiting?
Yes, NCT05488548 is actively recruiting participants. Contact the research team at studies@epigenetix.com for enrollment information.
Where is the NCT05488548 trial being conducted?
This trial is being conducted at Phoenix, United States, Jacksonville, United States, Boston, United States, Rochester, United States and 2 additional locations.
Who is sponsoring the NCT05488548 clinical trial?
NCT05488548 is sponsored by Epigenetix, Inc.. The principal investigator is Judy Chiao, MD at Epigenetix, Inc.. The trial plans to enroll 75 participants.
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