A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
University of Washington/Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
Judy Chiao, MD
studies@epigenetix.com
(561) 865-6098
Time Frame
Start Date: 2022-12-21
Estimated Completion Date: 2025-05
Participants
Target number of participants: 75
Treatments
Experimental: Part 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.
Experimental: Part 2
Patients will be assigned escalated dose according to BOIN design. The starting dose is 20 mg orally once a day for 14 consecutive days followed by 14 days of rest.
Experimental: Part 3
Patients will be assigned escalated dose according to BOIN design. The starting dose is 10 mg orally once a day for 14 consecutive days in combination with ruxolitinib or momelotinib followed by 14 days of rest according to the traditional 3 + 3 design by the modified Fibonacci sequence
Sponsors
Leads: Epigenetix, Inc.

This content was sourced from clinicaltrials.gov

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