An Open-Label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors - E7386-J081-102

Eisai Limited0 sites196 target enrollmentDecember 22, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Eisai Limited
Enrollment: 196
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 22, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eisai Limited

Eligibility Criteria

Inclusion Criteria

•Subjects with confirmed diagnosis of advanced or unresectable or recurrent solid tumor and consent to biopsy before the enrollment of this study. If investigators judge that biopsy causes any concerns about ensuring subject safety, or if subject has no accessible non\-target lesion, the investigator must submit archival tumor samples. Subjects without either archival tumor samples or a new biopsy may be eligible after discussion with the Sponsor For HCC subjects only Subjects with confirmed diagnosis of unresectable HCC with any of the following criteria: a. Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio\-HCC tumors b. Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection (see Appendix 11\) For other ST subjects (ie, except for HCC subjects) Subjects with histologically or cytologically confirmed diagnosis of solid tumor for which no alternative standard therapy or no effective therapy exists (see details in inclusion criteria \#18 and \#19 for CRC and EC Subparts, respectively)., Adequate liver function: a. Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) b. Total bilirubin c. Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST), Adequate serum mineral level: a. Calcium (albumin\-corrected) within normal range Albumin\-corrected calcium concentration (mg/dL) \= actual calcium concentration (mg/dL) \+4 – serum albumin concentration (g/dL) b. Potassium \=lower limit of normal (LLN) c. Magnesium, Willing and able to give informed consent and comply with all aspects of the protocol., At least one measurable lesion based on modified RECIST (mRECIST; for HCC Subparts in Dose Escalation Part \[see Appendix 5]) or on RECIST 1\.1 (see Appendix 4\) meeting following criteria (for Other ST Subparts in Dose Escalation Part and all subparts in Expansion Part) meeting following criteria \- At least 1 lesion of \=1\.0 cm in the longest diameter for a non\-lymph node or \=1\.5 cm in the short\-axis diameter for a lymph node that is serially measurable according to RECIST 1\.1 using computerized tomography (CT)/magnetic resonance imaging (MRI) \- Lesions that have had external beam radiotherapy or loco\-regional therapies such as radiofrequency ablation, or transarterial chemoembolization (TACE)/transarterial embolization (TAE) must show evidence of disease progression based on RECIST 1\.1 to be deemed a target lesion, For HCC subjects only: Child\-Pugh score A (see Appendix 6\). Note: If Child\-Pugh score 7 or more was observed during Screening or Baseline, the subject is ineligible and re\-assessment of the Child\-Pugh score is not permitted, For HCC subjects only: Subjects categorized to stage B (not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system (see Appendix 7\)., see protocol, For HCC Subpart in Expansion Part only: prior systemic therapy for locally advanced or metastatic disease is as defined below a. Subjects who have received only 1 prior line of IO\-based regimen and have progressed on or after prior treatment with IO\-based regimen, or IO ineligible subjects who have received no prior systemic therapy. Subjects who previously received lenvatini

Exclusion Criteria

•Any of cardiac conditions as follows: \- Heart failure New York Heart Association (NYHA) (see Appendix 8\) Class II or above \- Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted \- Prolongation of corrected QT (QTcF) interval to \>480 ms \- Left ventricular ejection fraction (LVEF) \<50%, Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, or vomiting) that might impair the bioavailability of E7386 or lenvatinib., see protocol, Any of bone disease/conditions as follows \- Osteoporosis with T\-score of \- 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 \- Bone metastasis requiring orthopedic intervention \- Bone metastasis not being treated by bisphosphonate or denosumab. Subject may be included if treatment with bisphosphonate or denosumab have been started at least 14 days prior to the first dose of study drug. Subjects 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% to 40% decrease in the height of any vertebrae) or severe (\>40% decrease in the height of any vertebrae) morphometric vertebral fracture at Baseline, see protocol, Any condition that in the assessment of the investigator interferes with the investigation., History of malignancy (except for original disease, or definitively treated melanoma in situ, basal or squamous cell carcinoma of the skin, carcinoma in situ \[eg, bladder or cervix]) within the past 24 months prior to the first dose of study drug, Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta\-human chorionic gonadotropin \[ß\-hCG] or human chorionic gonadotropin \[hCG] with a minimum sensitivity of 25 IU/L or equivalent units of ß\-hCG \[or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug., Females of childbearing potential who: Within 30 days before study entry, did not use a highly effective method of contraception, which includes any of the following a. total abstinence (if it is their preferred and usual lifestyle)\* b. an intrauterine device (IUD) or intrauterine hormone\-releasing system (IUS) c. a contraceptive implant d. an oral contraceptive (subject must have been on a stable dose of the same oral contraceptive product for at least 30 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 180 days after study drug discontinuation) e. have a vasectomized partner with confirmed azoospermia Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for at least 180 days after study drugs discontinuation For sites outside of the EU and UK, it is permissible that if a highly effective me