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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicities (DLT)

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3Experimental Treatment1 Intervention

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

Group II: Part 2Experimental Treatment1 Intervention

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.

Group III: Part 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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