A Study of E7130 in Participants With Solid Tumors

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.

Criteria

Inclusion Criteria:

• Participants who have provided voluntary written consent for participation in this clinical study

• Participants to whom the rules for complying with this clinical study have been adequately explained, and who intend to and can comply with those rules

• Participants age greater than or equal to (>=) 20 years at the time of informed consent

• Participants with adequate function of major organs

• Participants with Performance Status score of 0 to 1 established by the Eastern Cooperative Oncology Group

• Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug

• Washout period required from the end of prior treatment to the first administration of study drug

• Participants agree to submit blood samples prior and during study treatment for progressive disease markers.

Inclusion Criteria (Part 2 only):

• Measurable disease meeting the following criteria:

1. At least 1 lesion of >=1.0 centimeter (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 response evaluation criteria in solid tumours (RECIST) 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI).

2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.

Exclusion Criteria:

• Medical history of clinically significant cardiovascular impairment

• Concomitant systemic infection requiring medical treatment (including bacterial infection and fungal infection)

• Participants who test positive for human immunodeficiency virus (HIV antibody)

• Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs)/hepatitis B core antibody (HBcAb) and anti-hepatitis C virus (HCV) antibody test.

• Effusion requiring drainage

• Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia)

• Other active malignancy

• 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]).

• Women of childbearing potential or men of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception during the study and after study drug discontinuation (male; 90 days, female; 60 days)

• Known intolerance to the study drug or any of the excipients

• Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study

• Scheduled for surgery during the study

• Diagnosed with meningeal carcinomatosis

• Participants with brain or subdural metastases are not eligible.