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OncoMatch/Clinical Trials/NCT05488548

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

Is NCT05488548 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies EP31670 for castrate resistant prostate cancer.

Phase 1RecruitingEpigenetix, Inc.NCT05488548Data as of May 2026

Treatment: EP31670A 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

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Acute Myeloid Leukemia

Myeloproliferative Neoplasm

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: antiandrogen

Relapse or refractory castration-resistant prostate cancer (CRPC) following at least one anti-androgen regimen

Must have received: taxane (docetaxel)

Relapse or refractory castration-resistant prostate cancer (CRPC) following ... a docetaxel-containing regimen

Must have received: hypomethylating agent

relapsed or refractory CMML following at least 4 cycles of hypomethylating agent-containing regimen

Must have received: hydroxyurea (hydroxyurea)

relapsed or refractory CMML following ... hydroxyurea unless demonstration of progression or intolerance

Must have received: JAK inhibitor

advanced MF (intermediate or high-risk) following at least one JAK inhibitor-containing regimen

Lab requirements

Blood counts

Hemoglobin ≥ 9.0 g/dL (Part 1); ANC ≥ 1,500/dL (Part 1); Platelet count ≥100,000/μL (Part 1) or ≥75,000/μL (Part 3)

Kidney function

Creatinine clearance (CLcr) ≥ 60 mL/min

Liver function

total bilirubin ≤ 1.5 x ULN; ALT or AST ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases

Cardiac function

Internal normalized ratio for prothrombin time (INR) ≤ 1.2 in patients not receiving chronic anticoagulation; Corrected QT interval <470 msec

Adequate bone marrow function: Hemoglobin ≥ 9.0 g/dL (Part 1); 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; ALT or 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. Corrected QT interval <470 msec.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic Arizona · Phoenix, Arizona
  • Mayo Clinic Florida · Jacksonville, Florida
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • Mayo Clinic Rochester · Rochester, Minnesota
  • The University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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