A Phase 1 interventional study of E7386 in Advanced Neoplasms, sponsored by Eisai Inc.. Active, not recruiting at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Eisai Inc. · Phase 1, Interventional, and Treatment
This study will be conducted to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
Participant must have any of the following tumor types, confirmed by available histology or cytology records or current biopsy, that is advanced, nonresectable, recurrent since last antitumor therapy, in need of systemic treatment, and for which no alternative standard therapy exists:
HCC participants must have:
i. Confirmed diagnosis of HCC ii. Barcelona Clinical Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to local therapy.
Measurable disease meeting the following criteria:
Adequate bone marrow function:
Adequate liver function:
Exclusion Criteria:
Bone metastases and one of the following:
Females of childbearing potential who:
For participants with HCC, participants are excluded if:
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.
Drug: E7386
Oral immediate release tablets.
Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs are any of the pre-specified drug-related toxicities (any toxicities considered related to E7386) occurring during Cycle 1 as assessed by the investigator. DLTs will be assessed to determine the maximum tolerated dose.
Time frame: Cycle 1 (28 days)
Recommended Phase 2 Dose (RP2D)
RP2D will be selected based on an integrated evaluation of safety, tolerability, efficacy, pharmacokinetic (PK) data, and any available pharmacodynamic (PD) data for all dose levels or all available data according to pre-specified guidelines.
Time frame: Cycle 1 (28 days)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From the date of first dose of study drug up to 28 days after administration of study drug (up to approximately 6 years and 10 months)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to approximately 6 years and 10 months
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 disease progression or death, whichever occurs first. Disease progression, per RECIST 1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to approximately 6 years and 10 months
Maximum Drug Concentration (Cmax) of E7386
Cmax is the maximum plasma concentration of a drug after administration.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Time to Reach the Maximum Concentration Following Drug Administration (tmax) of E7386
tmax is the time to reach maximum concentration following drug administration.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Area Under the Concentration Versus Time Curve (AUC) of E7386
AUC is a measure of actual body exposure to drug after administration of the drug.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Elimination Half-life (t1/2) of E7386
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Apparent Total Body Clearance (CL/F) of E7386
CL/F is the volume of plasma cleared of drug per unit time.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Volume of Distribution (Vd) of E7386
Vd is the apparent volume in which a drug is distributed.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Renal Clearance (CLr) of E7386
Time frame: Cycle 1 Days 1 and 8: 0-24 hours postdose (Dose Escalation) (each Cycle = 28 Days)
Accumulation Ratio (R) of E7386
R indicates the extent to which drug accumulates.
Time frame: Cycle 1 Days 1 and 8: 0-12 hours postdose (Dose Escalation); Cycle 1-4 Day 1: 0-1 hours postdose (Dose Expansion) (each Cycle = 28 Days)
Fraction Excreted (fe) of E7386
Time frame: Cycle 1 Days 1 and 8: 0-24 hours postdose (Dose Escalation) (each Cycle = 28 Days)
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Eisai Inc.