E7386 for Advanced Cancer

Not currently recruiting at 9 trial locations

Overseen By Eisai Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eisai Inc.

Must be taking: Vitamin D

Must not be taking: CYP3A4 inducers/inhibitors

Disqualifiers: Active malignancy, Brain metastases, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, E7386, for individuals with advanced or recurring cancers lacking standard treatment options. The primary goal is to assess the safety of E7386 and determine the optimal dose for future studies. The study focuses on cancers such as endometrial cancer and melanoma that have progressed despite previous treatments. Individuals with cancers requiring systemic treatment and no other options may be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how E7386 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically those that are known potent CYP3A4 inducers/inhibitors or sensitive substrates, at least 4 weeks before starting the study drug. If you're on such medications, you may need to stop them before participating.

Is there any evidence suggesting that E7386 is likely to be safe for humans?

Research has shown that E7386 has undergone testing in other studies to assess its safety for humans. One study found that when combined with another drug, E7386 had a manageable safety profile, meaning the treatment caused side effects that doctors could handle, even in patients with advanced cancer. Another report updated findings on E7386 when used alone, focusing on its safety and tolerability. These studies suggest that E7386 is generally well-tolerated, with manageable side effects.

This current study is in an early phase, primarily to evaluate the safety of E7386 on its own. Safety data is still being collected, and researchers aim to determine the best dose for future use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about E7386 because it offers a novel approach to treating advanced cancer by targeting the Wnt/beta-catenin signaling pathway, which is often implicated in cancer development and progression. Unlike many standard treatments that focus on attacking the cancer cells directly, E7386 aims to disrupt the communication that allows cancer cells to grow uncontrollably. This unique mechanism of action could potentially offer new hope for patients who have not responded well to existing therapies. With its oral administration and potential to be adjusted based on individual patient responses, E7386 might provide a more personalized treatment option for those battling advanced cancer.

What evidence suggests that E7386 might be an effective treatment for advanced cancer?

Research has shown that E7386, when combined with lenvatinib, has promising effects against tumors in advanced cancer cases. Studies have found that this combination extends the lifespan of animals compared to using either drug alone. E7386 targets specific cancer pathways, potentially stopping cancer cell growth. Early findings suggest it could control tumor growth in patients with advanced, inoperable cancers. Although more information is needed about E7386 alone, these early results are encouraging for its potential effectiveness. Participants in this trial will receive E7386 as a single agent to further evaluate its safety and effectiveness. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults with a life expectancy of at least 12 weeks and certain advanced tumors who've recovered from previous cancer treatments can join. They must have an ECOG Performance Status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Specific tumor types for different trial parts are required, along with measurable disease, normal organ function, and agreement to vitamin D supplements.

Inclusion Criteria

Ability to comply with protocol

Written informed consent

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had any cancer except for certain types in the last 2 years.

I have recently undergone treatment for cancer.

I am taking medication that affects CYP3A4 enzymes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive E7386 orally twice daily in 28-day cycles to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D)

28 days per cycle

Dose Expansion

Participants continue to receive E7386 at the determined RP2D to further assess safety and efficacy

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 6 years and 10 months

What Are the Treatments Tested in This Trial?

Interventions

• E7386

Trial Overview The trial is testing the safety and tolerability of E7386, an oral medication for various advanced cancers. It aims to find the highest dose patients can take without serious side effects (MTD) and suggest a Phase 2 dose (RP2D). Participants will be selected based on their type of cancer and health status.

How Is the Trial Designed?

Group I: E7386 BID Experimental Treatment 1 Intervention

E7386 will be administered as a single agent orally, initially twice daily (BID) continuously in 28 days treatment cycle. The dose will be escalated in cohorts of participants subject to safety data and the absence of DLTs. Based on the emerging data after completion of Dose Escalation Part, identifying MTD or RP2D, or after a decision is made to evaluate more than one potential RP2D level, a Dose Expansion Part will be initiated. Participants will continue to receive study treatment in extension phase until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study program.

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5599

Global dose-expansion cohort of E7386 + lenvatinib (LEN) ... E7386 study 102: Global dose-expansion cohort of E7386 + lenvatinib (LEN) in patients (pts) with advanced endometrial cancer (aEC) that ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40318924/

Randomized study evaluating optimal dose, efficacy, and ... E7386 plus lenvatinib will show a manageable safety profile and clinically meaningful anti-tumor activity in patients with advanced, un-resectable, or ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X25009314

Clinical Trials Randomized study evaluating optimal dose ... E7386 plus lenvatinib will show a manageable safety profile and clinically meaningful anti-tumor activity in patients with advanced, un-resectable, or ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-0725/766879/E7386-Enhances-Lenvatinib-s-Antitumor-Activity-in

E7386 Enhances Lenvatinib's Antitumor Activity in Preclinical ... Results: E7386 in combination with lenvatinib significantly prolonged mouse survival compared with monotherapy. Cell lines and patient-derived ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03833700?term=AREA%5BConditionSearch%5D(cancer%20OR%20carcinoma)%20AND%20AREA%5BBasicSearch%5D(eisai)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20NOT_YET_RECRUITING%20OR%20ACTIVE_NOT_RECRUITING%20OR%20ENROLLING_BY_INVITATION)&rank=1

A Study of E7386 in Participants With Advanced Solid ... The study will be conducted in 3 parts: dose escalation part, expansion part 1 and expansion part 2. The study will consist of Primary Assessment Phase and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04008797

NCT04008797 | A Study of E7386 in Combination With ... The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.106

A phase 1 study of E7386, a CREB-binding protein (CBP)/β ... Here we describe an update of the dose-escalation part of this phase 1 study—we mainly report updated safety, tolerability, and preliminary ...