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BET and CBP/p300 Inhibitor
EP31670 for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Epigenetix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced cancer in humans for the first time.
Who is the study for?
This trial is for adults with certain advanced solid tumors, like prostate cancer or neuroendocrine tumors. Participants must be relatively healthy and active (ECOG 0-1), have a life expectancy of at least 3 months, and proper organ function. They should not have had recent cancer treatments or major surgery and must agree to use contraception. It's not for pregnant women, those with severe heart issues, uncontrolled illnesses, or specific viral infections.Check my eligibility
What is being tested?
EP31670 is being tested in this Phase 1 trial. It's a first-in-human study focusing on patients with targeted advanced solid tumors who may benefit from dual BET and CBP/p300 inhibition—a new approach aimed at stopping tumor growth by targeting specific proteins involved in cancer cell survival.See study design
What are the potential side effects?
Since EP31670 is an investigational drug being studied for the first time in humans, potential side effects are unknown but could include typical reactions seen with other cancer therapies such as fatigue, nausea, blood count changes, liver function alterations, and possibly others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicities (DLT)
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Epigenetix, Inc.Lead Sponsor
Judy Chiao, MDStudy DirectorEpigenetix, Inc.
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving antiviral treatment for hepatitis B or C.I am fully active or can carry out light work.It has been at least 4 weeks since my major surgery.My cancer can be measured or evaluated.My brain cancer has not worsened after treatment and I am neurologically stable.I finished my last cancer treatment 4 weeks ago and have recovered from its side effects.My liver is working well, according to recent tests.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My blood tests show normal levels of hemoglobin, neutrophils, and platelets.I don't have severe illnesses or mental health issues that could affect my study participation.I have advanced prostate cancer or a rare cancer that has not responded to standard treatments.My kidney function is good, with a filtration rate of at least 60 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could patients participating in Arm 1 be exposed to risk?
"The safety of Arm 1 can be assessed at a score of 1, as it is currently undergoing Phase 1 clinical trials. This indicates that there has been minimal data collected on its efficacy and safety."
Answered by AI
How many individuals have enrolled to partake in this exploration?
"Epigenetix, Inc., the sponsor of this clinical trial, is in search of 50 suitable candidates. The study will be administered at two locations: MD Anderson Cancer Center and Fred Hutchinson Cancer Center."
Answered by AI
Is it feasible to apply for participation in this research endeavor at the present time?
"Affirmative. Online records on clinicaltrials.gov show that this medical trial began recruiting patients on December 21st, 2022 and is currently active. 50 individuals are needed at 3 clinics for the study to be a success."
Answered by AI
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