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Solid NeoplasmsPhase 1NCT03833700

A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

A Phase 1 study testing E7386 in people with Solid Neoplasms and Colorectal Neoplasms, run by Eisai Co., Ltd. at 8 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will be conducted to assess the safety and tolerability of E7386 in participants with solid tumor including CRC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
E7386
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
8 sitesJapan
Study dates
5 Mar 2019to 31 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Participants with a histological and/or cytological diagnosis of solid tumor must have any of the following tumor types:
  • Dose Escalation Part: Participants with advanced, unresectable, or recurrent solid tumor including CRC for which no alternative standard therapy or no effective therapy exists
  • Expansion Part 1: Participants with advanced, unresectable, or recurrent CRC in third- or later-line, Or participants with other gastrointestinal tumors such as small bowel carcinoma and gastrointestinal neuroendocrine tumors after at least 1 prior systemic chemotherapy regimen upon discussion and agreement with the sponsor
  • Expansion Part 2: Participants with advanced, unresectable, or recurrent solid tumors expected to be highly dependent on wingless/integrated (Wnt)/β-catenin signaling pathway as specified below, who have no standard therapy. Disease progression must be confirmed within the past 12 months.
  • Desmoid tumor
  • Solid pseudopapillary neoplasm (SPN) of pancreas
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  • Small bowel carcinoma with mutation of catenin beta-1 (CTNNB1) or adenomatous polyposis coli (APC)
  • Adrenocortical carcinoma (ACC) with mutation of CTNNB1, APC or zinc and ring finger 3 (ZNRF3)
  • Solid tumors (except for CRC) with APC mutation in participants diagnosed as familial adenomatous polyposis (FAP)
  • Hepatocellular carcinoma (HCC) with CTNNB1 gain-of-function mutation
  • Other types of solid tumors (except for CRC) harboring one or more Wnt-related gene mutations (example, APC, AXIN1, CTNNB1, ring finger protein 43 [RNF43], et cetera) expected to be highly dependent on Wnt/β-catenin signaling pathway based on emerging data may be enrolled upon consultation and agreement with the sponsor.
  • HCC participants must have:
  • A diagnosis of HCC that is histologically or cytologically confirmed (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors) or clinically confirmed according to American Association for the Study of Liver Disease criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection.
  • Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
  • Life expectancy of >=12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • All AEs due to previous anti-cancer therapy have either returned to Grade 0-1 except for alopecia and Grade 2 peripheral neuropathy (renal/bone marrow/liver function should meet the inclusion criteria).
  • Adequate washout period before study drug administration:
  • Chemotherapy and radiotherapy: 3 weeks or more
  • Any therapy with antibody (Ab): 4 weeks or more
  • Any investigational drug or device: 4 weeks or more
  • Blood/platelet transfusion or Granulocyte-colony stimulating factor (G-CSF): 2 weeks or more
  • Adequate renal, bone marrow, liver function, and serum mineral level.
  • At least one measurable lesion based on RECIST 1.1.
  • Dose escalation part: Participants must consent to skin biopsies from skin tissue that is tumor-free during the study. Expansion part 1: At least 5 participants in each dose level must consent to skin biopsies from skin tissue that is tumor-free during the study. Participants may be enrolled without skin biopsies upon consultation and agreement by the sponsor. Expansion part 2: Participants must consent to skin biopsies from skin tissue that is tumor-free during the study in principle. Participants may be enrolled without consent to skin biopsies upon consultation and agreement by the sponsor.

Who cannot join

  • Known to be human immunodeficiency virus (HIV) positive.
  • Active infection requiring systemic treatment.
  • For participants with HCC in Expansion part 2: In case of Hepatitis B surface antigen (HBsA g) positive (+) participants:
  • Antiviral therapy for Hepatitis B virus (HBV) is not ongoing
  • HBV viral load is 2000 International units per milliliter (IU/mL) or more at the Screening Period although antiviral therapy for HBV is ongoing
  • Has dual active HBV infection (HBsAg [+] and/or detectable HBV Deoxyribonucleic acid [DNA]) and Hepatitis C virus (HCV) infection (anti-HCV Ab [+] and detectable HCV Ribonucleic acid [RNA]) at study entry
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  • Diagnosed with meningeal carcinomatosis.
  • Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
  • Any of bone disease/conditions as follows;
  • Osteoporosis with T-score less than (<) -3 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by dual energy X-ray absorptiometry (DXA) scan. Participants with T-score <-2.5 to -3.0 and no prior medical therapy for osteoporosis can only be included provided that treatment with a bisphosphonate (example, zoledronic acid) or denosumab has been started at least 14 days prior to the first dose of study drug
  • Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
  • Symptomatic hypercalcemia requiring bisphosphonate therapy
  • History of any fracture within 6 months prior to starting study drug
  • Any condition requiring orthopedic intervention
  • Bone metastasis, not being treated by bisphosphonate or denosumab. Participant may be included if treatment with bisphosphonate or denosumab have been started at least 14 days prior to the first dose of study drug. Participants with previous solitary bone lesions controlled with radiotherapy are eligible
  • History of symptomatic vertebral fragility fracture or any fragility fracture of the hip, pelvis, wrist or other location (defined as any fracture without a history of trauma or because of a fall from standing height or less)
  • Moderate (25 percent [%] to 40% decrease in the height of any vertebrae) or severe (more than [>] 40% decrease in the height of any vertebrae) morphometric vertebral fracture at baseline.
  • History of active malignancy (except for original disease, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug.
  • For participants with HCC in Expansion part 2, if the participants have:
  • Child-Pugh status of B and C
  • History of hepatic encephalopathy within 6 months prior to starting study drug unresponsive to therapy within 3 days. Participants on rifaximin or lactulose during screening to control their hepatic encephalopathy are not allowed

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Eisai Trial Site #1

    Chuo Ku, Tokyo

  • Eisai Trial Site #4

    Fukuoka

  • Eisai Trial Site #2

    Kashiwa, Chiba

  • Eisai Trial Site #3

    Nagaizumi-cho, Shizuoka

  • Eisai Trial Site#7

    Nagoya, Aichi-ken

  • Eisai Trial Site#6

    Osaka

  • Eisai Trial Site #5

    Sapporo, Hokkaido

  • Eisai Trial Site#8

    Sendai, Miyagi

Other trials in Japan

About this study

Official title: An Open-label Phase 1 Study of E7386 in Subjects With Advanced Solid Tumor Including Colorectal Cancer

This study will be conducted to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

Read the detailed description

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 Continuation Phase. Primary Assessment Phase will include Pre-treatment Phase, Treatment Phase and Extension Phase (in expansion parts only).

After Treatment Phase, participants will be followed in follow-up period of Extension Phase (in expansion parts only). All participants who are still on study drug at the time of data cutoff date for the planned primary analysis will enter the Continuation phase and continue to receive E7386.

Being tested
E7386
Keywords
Solid Tumor, Colorectal Cancer, E7386, Small Bowel Carcinoma, Gastrointestinal Neuroendocrine Tumor, Adrenocortical carcinoma, Desmoid Tumor, Solid pseudopapillary neoplasm of pancreas, Hepatocellular carcinoma
Medical subject headings
Colorectal Neoplasms, Digestive System Neoplasms, Gastro-enteropancreatic neuroendocrine tumor, Adrenocortical Carcinoma, Desmoid Tumors, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7386Drug

    E7386 doses.

Study groups in NCT03833700
Study groupRoleWhat they receive
Dose Escalation Part: E7386ExperimentalParticipants will receive E7386 in 28-days treatment cycle until disease progression (PD), development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program.
Receives: Drug: E7386
Expansion Part 1ExperimentalParticipants will receive E7386 in 28-days treatment cycle until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program.
Receives: Drug: E7386
Expansion Part 2ExperimentalParticipants will receive E7386 in 28-days treatment cycle until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program.
Receives: Drug: E7386

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose-limiting Toxicities (DLTs)

    DLT will be defined as any of the events that are considered by the investigator to be at least possibly related to therapy with the study medication. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

    Measured: Baseline up to Cycle 1 (Cycle length is equal to [=] 28 days)

  2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment (approximately 6 years)

Secondary outcomes (11)

  1. Cmax: Maximum Observed Plasma Concentration for E7386

    Measured: Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days)

  2. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386

    Measured: Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days)

  3. AUC: Area Under the Plasma Concentration Versus Time Curve for E7386

    Measured: Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days)

  4. CL/F: Apparent Total Body Clearance for E7386

    Measured: Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days)

  5. Vz/F: Apparent Volume of Distribution for E7386

    Measured: Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days)

  6. Objective Response Rate (ORR)

    The ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The ORR will be assessed by investigator based on RECIST version 1.1.

    Measured: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years)

  7. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD). The DCR will be assessed by investigator based on RECIST version 1.1.

    Measured: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years)

  8. Clinical Benefit Rate (CBR)

    The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD. The CBR will be assessed by investigator based on RECIST version 1.1.

    Measured: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years)

  9. Progression-free Survival (PFS)

    PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed PD or death, whichever occurs first.

    Measured: From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 6 years)

  10. Duration of Response (DOR)

    DOR is defined as the time from the first date of documented CR or PR to the date of PD or death, whichever occurs first. It will be calculated for participants whose BOR is CR or PR. DOR will be assessed according to RECIST version 1.1.

    Measured: From the date of first documented CR or PR until first documentation of PD or death (up to approximately 6 years)

  11. Overall Survival (OS)

    OS is defined as the time from the date of first dose to the date of death.

    Measured: From first dose of study drug until date of death (up to approximately 6 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2019
  2. Study start5 Mar 2019
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833700
Sponsor's protocol ID
E7386-J081-103
Status last verified
Feb 2026
First submitted
6 Feb 2019
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7386 in people with Solid Neoplasms and Colorectal Neoplasms, run by Eisai Co., Ltd. at 8 sites in Japan.

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 25 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: Baseline up to Cycle 1 (Cycle length is equal to [=] 28 days)). The study lists 2 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 NCT03833700.

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 27 Feb 2026.

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