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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 (Jun 2026). This Phase 1 trial studies EP31670 for castrate resistant prostate cancer.

Phase 1RecruitingEpigenetix, Inc.NCT05488548Data as of Jun 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

Treatments studied

Other

EP31670

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 →

Frequently asked questions

Is NCT05488548 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received antiandrogen and taxane.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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