Study of ESG401 in Adults With Solid Tumors

Inclusion Criteria:

• Individuals able to understand and give written informed consent.

• Subjects must have a histologically or cytologically confirmed advanced ormetastatic solid tumor(s) for which no effective standard therapy is available ortolerable.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy ≥12 weeks.

• Subject must have adequate organ function

• Fertile men and women of childbearing potential must agree to use an effectivemethod of birth control from providing signed consent and for 180 days after lastinvestigational product administration. Women of childbearing potential includepre-menopausal women and women within the first 2 years of the onset of menopause.

Exclusion Criteria:

• Subjects receiving cancer therapy (chemotherapy or other systemic anti-cancertherapies, immunotherapy, or radiation therapy) within 4 weeks before the firstinvestigational product administration..

• Has not recovered from adverse events (e.g., returned to baseline or grade 0~1) dueto a previously administered agent.

Note: Subjects with Grade 2 alopecia or anemia are exceptions to this criterion and may qualify for the study.

• Had major surgery within 4 weeks before dosing, or will not have fully recoveredfrom surgery; or has surgery planned during the time the subject is expected toparticipate in the study or within 4 weeks after the last dose of study drugadministration.

• Use of any investigational anti-cancer drug within 28 days before the firstinvestigational product administration.

• New thromboembolic events, intestinal obstruction, gastrointestinal bleeding orperforation within 6 months

• Uncontrolled systemic bacterial, viral or fungal infections

• Subjects with symptomatic or untreated CNS metastases, or those requiring ongoingtreatment for CNS metastases.

• Primary CNS malignancy; Or a second primary tumor other than the confirmed solidtumor within the previous 3 years

• Evidence of serious or uncontrolled systemic disease (e.g., unstable ordecompensated respiratory disease, liver disease or kidney disease)

• Patients with gastrointestinal diseases (such as chronic gastritis, chronicenteritis or gastric ulcers), or with a previous history of severe or chronicdiarrhea

• History of chronic skin disease and present skin disease (e.g. bullous dermatitis,acnelike rash, skin ulcer, etc.)

• Subjects with clinically significant cardiovascular disease as defined by thefollowing:

• Baseline left ventricular ejection fraction (LVEF) ≤ 50% measured byEchocardiogram (ECHO) or Multi-gated acquisition (MUGA)

• Heart failure New York Heart Association (NYHA) Class II or above

• Uncontrolled hypertension (BP ≥ 150/95 mmHg despite optimal therapy)

• Prior or current cardiomyopathy

• Atrial fibrillation with heart rate > 100 bpm

• Unstable ischaemic heart disease (myocardial infarction (MI) within 6 monthsprior to starting treatment, or angina requiring use of nitrates more than onceweekly)

• QTc interval >/= 450 msecs for male or >/= 470 msecs for female (Fridericia'sformula: QTc=QT/RR0.33).

• Human Immunodeficiency Virus (HIV) infection.

• Subjects who are Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive at screening must notbe enrolled until further definite testing with Hepatitis B virus (HBV) DNA titresand HCV RNA tests can conclusively rule out presence of active infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring antiviral therapy with Hepatitis B and C,respectively

• Known immediate or delayed hypersensitivity reaction to irinotecan or othercamptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinalreactions associated with irinotecan, or allergies, or to any investigational drugor excipient ingredient

• Concurrent condition that in the investigator's opinion would jeopardize compliancewith the protocol.

• Unwillingness or inability to follow the procedures outlined in the protocol.