EP31670 for Advanced Cancer

Recruiting at 5 trial locations

Overseen By Judy Chiao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Epigenetix, Inc.

Must not be taking: Antibiotics, Antifungals

Disqualifiers: CNS metastasis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks per cycle

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires a four-week period without prior anti-cancer therapy, including chemotherapy, immunotherapy, or investigational anti-cancer therapy, before starting the study. This suggests you may need to stop certain medications, but the protocol does not specify all medications that must be stopped.

What safety data exists for EP31670 or similar treatments in humans?

The safety of oral anticancer drugs, like EP31670, has been studied, showing that they can cause side effects such as heart problems and issues with fat metabolism. These side effects are common with many cancer treatments, and healthcare providers often adjust doses to manage them. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Judy Chiao, MD

Principal Investigator

Epigenetix, Inc.

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

It has been at least 4 weeks since my major surgery.

Exclusion Criteria

I am receiving antiviral treatment for hepatitis B or C.

Corrected QT interval ≥470 msec

Pregnant or lactating women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EP31670 in a dose-escalation study to determine the maximum tolerated dose

3 weeks per cycle

Multiple visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• EP31670

Trial Overview 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.

Participant Groups

Group I: Part 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Epigenetix, Inc.

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

Over half of the oral antineoplastic agents (OAAs) approved by the European Medicines Agency (EMA) are associated with cardiotoxic adverse events, particularly blood pressure alterations and QT interval prolongation, highlighting the need for careful monitoring during treatment.

Specific dose adjustment recommendations exist for some OAAs regarding cardiotoxicity, such as those for QT prolongation and left ventricular ejection fraction (LVEF) decrease, emphasizing the importance of pre-treatment cardiovascular risk assessment and potential referral to cardio-oncology specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication guide for dose adjustment and management of cardiotoxicity and lipid metabolic adverse events of oral antineoplastic therapy. Ramos-Ruperez, E., Escudero-Vilaplana, V., Ruiz-Briones, P., et al.[2023]

Oral antineoplastic therapy can lead to various cardiovascular adverse events, with 20 studies highlighting significant cardiac issues such as reduced left ventricular ejection fraction, myocardial infarction, and heart failure.

Peripheral vascular events, including hypertension and thromboembolism, were also noted, indicating that patients undergoing oral cancer treatments should be monitored for both cardiac and vascular complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular adverse events associated with oral antineoplastic therapy. Silva, JMD., Lima, BDS., Araújo, TL., et al.[2019]

A structured guide was developed to enhance the safety and efficacy of oral antineoplastic agents (OAA) for onco-hematologic outpatients, addressing critical areas such as dosing, drug interactions, and adverse event management.

The guide serves as a checklist for pharmacists during patient education, aiming to standardize care and improve adherence, ultimately leading to better patient outcomes in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding pharmacist clinical interviews: a safety tool to support the education of patients treated with oral antineoplastic agents. Ribed, A., Escudero-Vilaplana, V., Romero-Jimenez, RM., et al.[2016]

A systematic review of 128 randomized clinical trials involving 47,432 patients showed that anticancer drugs provided a statistically significant benefit in progression-free survival (PFS) and overall survival (OS) compared to best supportive care, with hazard ratios of 0.58 and 0.82, respectively.

Despite these benefits, the absolute gains in survival were modest, with PFS extending by only 2.1 months and OS by 0.5 months, and there was a weak correlation between severe toxicity and treatment efficacy, indicating that higher toxicity did not necessarily lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and benefits of anticancer drugs in advanced cancer patients: A systematic review and meta-analysis. Moreau Bachelard, C., Coquan, E., du Rusquec, P., et al.[2022]

Targeted therapies for non-small cell lung cancer (NSCLC) have significantly improved treatment options, but their effectiveness can be compromised by issues like poor patient adherence and adverse events.

The review highlights the need for standardized monitoring protocols for the various toxicities associated with these therapies, which can include skin, gastrointestinal, lung, and heart-related side effects, to ensure better patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. Hines, JB., Bowar, B., Levine, E., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Medication guide for dose adjustment and management of cardiotoxicity and lipid metabolic adverse events of oral antineoplastic therapy. [2023]

2. Brazil pubmed.ncbi.nlm.nih.gov

Cardiovascular adverse events associated with oral antineoplastic therapy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Guiding pharmacist clinical interviews: a safety tool to support the education of patients treated with oral antineoplastic agents. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Risks and benefits of anticancer drugs in advanced cancer patients: A systematic review and meta-analysis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. [2023]