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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Epigenetix, Inc.
Study ID
NCT05488548
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Castrate Resistant Prostate Cancer
  • Chronic Myelomonocytic Leukemia
  • Myelofibrosis
  • NUT Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EP31670 — DRUG
    EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor.

Study Details

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

Key Dates

Start date
Dec 21, 2022
Status verified
Sep 2024
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Within 3 weeks (one cycle) of treatment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Clinical Trials Referral Office
855-776-0015
Jeanne Palmer, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
855-776-0015
James Foran, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Atish Choudhury, MD
877-442-3324
Jia Luo, MD
877-442-3324
Atish Choudhury, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Mrinal Patnaik, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Rabia Khan
[email protected]
713-563-4667
Sarina A Piha-Paul, MD (PRINCIPAL_INVESTIGATOR)
University of Washington/Fred Hutchinson Cancer CenterSeattleWashington98109
Harini Ramachandran
[email protected]
Michael Schweizer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZMayo Clinic Florida· Jacksonville, FLDana Farber Cancer Institute· Boston, MAMayo Clinic Rochester· Rochester, MNThe University of Texas MD Anderson Cancer Center· Houston, TXUniversity of Washington/Fred Hutchinson Cancer Center· Seattle, WA

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