Castrate Resistant Prostate CancerPhase 1NCT05488548
Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
A Phase 1 study testing EP31670 in people with Castrate Resistant Prostate Cancer and NUT Carcinoma, run by Epigenetix, Inc. at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castrate Resistant Prostate Cancer, NUT Carcinoma, Chronic Myelomonocytic Leukemia
- What is being tested?
- EP31670
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Dec 2022to May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 20Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Atish Choudhury, MD, 877-442-3324
Jia Luo, MD, 877-442-3324
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Rabia Khan, 713-563-4667, RKhan@MDAnderson.org
Sarina A Piha-Paul, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015
James Foran, MD
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015
Jeanne Palmer, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
Mrinal Patnaik, MD
- Recruiting
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Harini Ramachandran, phase1clinicaltrial@seattlecca.org
Michael Schweizer, MD
About this study
Official title: A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
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
Read the detailed description
EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor which has demonstrated antitumor activity in in vitro and in vivo models of human cancer. This Phase I open-label, multi-center, dose-escalation study will assess the safety and determine the maximum tolerated dose of EP31670 administered orally in patients with castration-resistant prostate cancer, NUT midline carcinoma and other targeted advanced solid tumors as well as chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other targeted hematological malignancies.
- Conditions
- Castrate Resistant Prostate Cancer, NUT Carcinoma, Chronic Myelomonocytic Leukemia, Myelofibrosis
- Being tested
- EP31670
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP31670Drug
Also called NEO2734
EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 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. Receives: Drug: EP31670 |
| Part 2 | Experimental | 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. Receives: Drug: EP31670 |
| Part 3 | Experimental | 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 Receives: Drug: EP31670 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD is the highest dose level at which ≤30% of patients experienced DLTs during cycle 1.
Measured: Within 3 weeks (one cycle) of treatment
Dose Limiting Toxicities (DLT)
DLT is any of the following adverse events (AEs) that occur during cycle 1.
Measured: Within 3 weeks (one cycle) of treatment
Recommended Phase 2 Dose (RP2D)
RP2D will be the MTD
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start21 Dec 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Castrate Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Dose escalation/de-escalation will follow rules by employing the Bayesian optimal interval (BOIN) method for Part 1 and Part 2 and traditional 3+ 3 by modified Fibonacci sequence for Part 3
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epigenetix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judy Chiao, MD, Study director, Epigenetix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488548
- Sponsor's protocol ID
- EP31670-01
- Status last verified
- Sep 2024
- First submitted
- 27 Jul 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eickhoff N, Bergman AM, Zwart W. Homing in on a Moving Target: Androgen Receptor Cistromic Plasticity in Prostate Cancer. Endocrinology. 2022 Oct 11;163(11):bqac153. doi: 10.1210/endocr/bqac153.
PubMed 36125208
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05488548
- Acronym / sponsor ID
- EP31670-01
- Conditions
- Castrate Resistant Prostate Cancer, NUT Carcinoma, Chronic Myelomonocytic Leukemia, Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Epigenetix, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor which has demonstrated antitumor activity in in vitro and in vivo models of human cancer. This Phase I open-label, multi-center, dose-escalation study will assess the safety and determine the maximum tolerated dose of EP31670 administered orally in patients with castration-resistant prostate cancer, NUT midline carcinoma and other targeted advanced solid tumors as well as chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other targeted hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalation/de-escalation will follow rules by employing the Bayesian optimal interval (BOIN) method for Part 1 and Part 2 and traditional 3+ 3 by modified Fibonacci sequence for Part 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: EP31670Patients 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. |
| Part 2 | Experimental | Drug: EP31670Patients 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. |
| Part 3 | Experimental | Drug: EP31670Patients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP31670Also: NEO2734EP31670 (also known as NEO2734) is a first-in-class dual BET and CBP/p300 inhibitor. | Drug | Part 1, Part 2, Part 3 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Within 3 weeks (one cycle) of treatment
MTD is the highest dose level at which ≤30% of patients experienced DLTs during cycle 1.
Dose Limiting Toxicities (DLT)
Time frame: Within 3 weeks (one cycle) of treatment
DLT is any of the following adverse events (AEs) that occur during cycle 1.
Recommended Phase 2 Dose (RP2D)
Time frame: through study completion, an average of 1 year
RP2D will be the MTD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 36125208Eickhoff N, Bergman AM, Zwart W. Homing in on a Moving Target: Androgen Receptor Cistromic Plasticity in Prostate Cancer. Endocrinology. 2022 Oct 11;163(11):bqac153. doi: 10.1210/endocr/bqac153.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Chiao, MD study director
Epigenetix, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EP31670 in people with Castrate Resistant Prostate Cancer and NUT Carcinoma, run by Epigenetix, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy Chiao, MD ((561) 865-6098, studies@epigenetix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Within 3 weeks (one cycle) of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.