NCT05091346 is a Phase 1, PHASE2 clinical trial of E7386 in Melanoma, sponsored by Eisai Inc..

Who is sponsoring NCT05091346?

NCT05091346 is sponsored by Eisai Inc..

What drugs are being tested in NCT05091346?

Interventions in NCT05091346: E7386, Pembrolizumab, Lenvatinib.

What condition does NCT05091346 study?

NCT05091346 studies Melanoma, Carcinoma, Hepatocellular, Colorectal Neoplasms.

Is NCT05091346 still recruiting?

NCT05091346 is currently completed. Last updated 24 October 2025.

Are results published for NCT05091346?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-24 · How we verify

NCT05091346

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Completed Phase 1, PHASE2 Results posted Last updated 24 October 2025

What this trial tests

Phase 1, PHASE2 trial testing E7386 in Melanoma in 89 participants. Completed in 15 October 2024.

Timeline

27 October 2021

Primary endpoint
15 October 2024

15 October 2024

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	27 October 2021
Primary completion	15 October 2024
Estimated completion	15 October 2024
Sites	32 locations across United Kingdom, Japan, United States, Spain

Drugs / interventions tested

E7386 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →
Carcinoma, Hepatocellular — all drugs for Carcinoma, Hepatocellular →
Colorectal Neoplasms — all drugs for Colorectal Neoplasms →

Sponsor

Eisai Inc. — full company profile →

Who can join

18 and older, any sex, with Melanoma or Carcinoma, Hepatocellular. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs) Primary · Cycle 1 (Cycle length=21 days)

DLT was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 based on investigator assessment. DLT was defined as any of the hematological or non-hematological toxicities events that: - Failure to administer greater than or equal to (\>=) 75 percentage (%) of the planned dosage of E7386 as a result of treatment-related toxicity; - Any treatment-related toxicity that causes the participant to discontinue treatment, even if the toxicity does not meet DLT criteria; - Prolonged delay (greater than \[\>\] 2 weeks) in initiating Cycle 2 due to

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	0

Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Primary · Up to 30 days after last dose of study drug (up to 12.73 months)

A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous.

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	6
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	6

Phase 1b Part: Number of Participants With Serious TEAEs Primary · Up to 90 days after last dose of study drug (up to 14.73 months)

An SAE was any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening (i.e., the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). An SAE was also counted as a TEAE if it eme

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	2

Phase 2 Part: Objective Response Rate (ORR) Primary · Up to 20.40 months

ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to less than \[\<\] 10 millimeters \[mm\]). PR: At least a 30 percent (%) decrease in sum of the diameters (SOD) of target lesions, taking as reference the screening SOD. Additionally, progression of target lesions must not be present.

Group	Value	95% CI
Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg	0.0	0.0 – 19.5
Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg	6.9	0.8 – 22.8
Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg	3.2	0.1 – 16.7

Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) Secondary · Up to 11.73 months

BOR was defined as CR, PR, stable disease (SD), progressive disease (PD), and not applicable (NA)/not evaluable (NE) as per RECIST version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	0

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	0

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	83.3
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	33.3

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	16.7
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	50.0

NA/NE

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	16.7

Phase 1b and Phase 2 Parts: Duration of Response (DOR) Secondary · Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months

DOR was defined as the time from the first documentation of CR or PR to the first documentation of PD or death due to any cause (whichever occurs first), in participants with confirmed CR or PR per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient i

Group	Value	95% CI
Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg	14.1	12.4 – NA
Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg	7.5	NA – NA

Phase 1b and Phase 2 Parts: Disease Control Rate (DCR) Secondary · Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months

DCR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or SD (after \>=5 weeks from the first dose) as per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	83.3	35.9 – 99.6
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	33.3	4.3 – 77.7
Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg	58.8	32.9 – 81.6
Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg	48.3	29.4 – 67.5
Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg	32.3	16.7 – 51.4

Phase 1b and Phase 2 Parts: Clinical Benefit Rate (CBR) Secondary · Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months

CBR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or durable SD (duration of SD \>=23 weeks) per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD.

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	16.7	0.4 – 64.1
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	16.7	0.4 – 64.1
Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg	11.8	1.5 – 36.4
Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg	13.8	3.9 – 31.7
Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg	16.1	5.5 – 33.7

Phase 2 Part: Number of Participants With TEAEs and Treatment-related TEAEs Secondary · Up to 30 days after last dose of study drug (up to 21.40 months)

A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous. Related TEAEs was defined as AE for which a causal relationship between the study drug and the AE was a reasonable possibility.

TEAEs

Group	Value	95% CI
Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg	17
Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg	28
Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg	30

Treatment Related TEAEs

Group	Value	95% CI
Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg	16
Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg	26
Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg	28

Phase 1b Part, Cmax: Maximum Observed Plasma Concentration for E7386 When Co-administered With Pembrolizumab Secondary · Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

Cmax was defined as the maximum plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis.

Cycle 1 Day 1

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	401	± 232.0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	472	± 82.1

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	386	± 240.0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	706	± 86.4

Phase 1b Part, Tmax: Time to Reach the Maximum Plasma Concentration for E7386 When Co-administered With Pembrolizumab Secondary · Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

Tmax was defined as the time to reach maximum observed plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis.

Cycle 1 Day 1

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	0.70	0.35 – 5.93
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	2.00	0.53 – 2.05

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	2.90	1.90 – 3.93
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	1.38	0.55 – 6.00

Phase 1b Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 When Co-administered With Pembrolizumab Secondary · Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 (pre-dose) to time of last quantifiable concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis.

Cycle 1 Day 1

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	874	± 192.0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	1400	± 52.5

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg	1830	± 180.0
Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg	2540	± 81.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg

Serious: 0/6 (0%)

Deaths: 6/6

Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg

Serious: 2/6 (33%)

Deaths: 5/6

Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg

Serious: 7/17 (41%)

Deaths: 8/17

Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg

Serious: 5/29 (17%)

Deaths: 16/29

Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg

Serious: 10/31 (32%)

Deaths: 26/31

Serious adverse events (24 terms)

Reaction	System	Phase 1b, Dose Escalation:…	Phase 1b, Dose Escalation:…	Phase 2, Dose Expansion, H…	Phase 2, Dose Expansion, M…	Phase 2, Dose Expansion, C…
Pyrexia	General disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—
Organ failure	General disorders	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—
Hepatic haemorrhage	Hepatobiliary disorders	—	—	—	—	—
Immune-mediated hepatitis	Hepatobiliary disorders	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—	—
Liver function test abnormal	Investigations	—	—	—	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—	—
Brain oedema	Nervous system disorders	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—
Urinary tract obstruction	Renal and urinary disorders	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—

Other adverse events (35 terms — click to expand)

Reaction	System	Phase 1b, Dose Escalation:…	Phase 1b, Dose Escalation:…	Phase 2, Dose Expansion, H…	Phase 2, Dose Expansion, M…	Phase 2, Dose Expansion, C…
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Osteoporosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—

Most-reported serious reactions: Pyrexia, Abdominal pain, Dysphagia, Intestinal obstruction, Rectal haemorrhage, Upper gastrointestinal haemorrhage, General physical health deterioration, Malaise.

Data from ClinicalTrials.gov NCT05091346 adverse events section.

Sponsor's own description

The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w
WNT signaling and cancer stemness.
Katoh M, Katoh M. · · 2022 · cited 122× · PMID 35837811 · DOI 10.1042/ebc20220016
WNT/β-catenin signaling in hepatocellular carcinoma: The aberrant activation, pathogenic roles, and therapeutic opportunities.
Gajos-Michniewicz A, Czyz M. · · 2024 · cited 56× · PMID 37692481 · DOI 10.1016/j.gendis.2023.02.050
Wnt/β-catenin mediated signaling pathways in cancer: recent advances, and applications in cancer therapy.
Wu X, Que H, Li Q, Wei X. · · 2025 · cited 33× · PMID 40495229 · DOI 10.1186/s12943-025-02363-1
Hepatocellular Carcinoma: Old and Emerging Therapeutic Targets.
Pessino G, Scotti C, Maggi M, Immuno-Hub Consortium. · · 2024 · cited 29× · PMID 38473265 · DOI 10.3390/cancers16050901
New Era of Immune-Based Therapy in Intrahepatic Cholangiocarcinoma.
Kawamura E, Matsubara T, Kawada N. · · 2023 · cited 19× · PMID 37568808 · DOI 10.3390/cancers15153993
Why Is Wnt/β-Catenin Not Yet Targeted in Routine Cancer Care?
de Pellegars-Malhortie A, Picque Lasorsa L, Mazard T, Granier F, et al · · 2024 · cited 12× · PMID 39065798 · DOI 10.3390/ph17070949
Current Landscape and Potential Challenges of Immune Checkpoint Inhibitors in Microsatellite Stable Metastatic Colorectal Carcinoma.
San-Román-Gil M, Torres-Jiménez J, Pozas J, Esteban-Villarrubia J, et al · · 2023 · cited 12× · PMID 36765821 · DOI 10.3390/cancers15030863

Verify or expand the search:

Other trials of E7386

Trials testing the same drug.

NCT04840927 — A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets · Phase 1 · withdrawn
NCT04008797 — A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor · Phase 1, PHASE2 · active not recruiting
NCT03996226 — A Food-Effect Study of E7386 in Healthy Participants · Phase 1 · completed
NCT03833700 — A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC) · Phase 1 · active not recruiting
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Other Eisai Inc. trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05091346 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 24 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05091346.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05091346

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (24 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of E7386

Other recruiting trials for Melanoma

Other Eisai Inc. trials

Verify against primary sources