A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors

Main

Inclusion Criteria:

- Males and females 18 years of age and older at the time of screening

- Anticipated life expectancy > 3 months at the time of screening

- Histologically confirmed malignant solid tumor which is refractory to or has failed
standard treatments, or subject is not considered medically suitable to receive
standard of care treatment or refuses standard of care treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Adequate hematological function (as defined in the study protocol)

- Adequate renal function (as defined in the study protocol)

- Adequate liver function (as defined in the study protocol)

- Adequate venous access

Main Exclusion Criteria:

- Known brain tumors or Central nervous system (CNS) metastases

- Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted
therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to
administration of the investigational product (IP) (6 weeks for nitrosoureas and
mitomycin C). Any previous treatment-related toxicities must have recovered to Grade
≤ 1 (graded according to the National Cancer Institute Common Terminology Criteria
for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone
deprivation therapies for hormone-refractory prostate cancer or breast cancer are
permitted.

- Major surgery within 4 weeks prior to IP administration

- Active infection requiring IV antibiotics within 2 weeks prior to screening

- Known history of hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis.
Known history of human immunodeficiency virus (HIV) type 1/2 or other
immunodeficiency disease.

- Participant has received a live vaccine within 4 weeks prior to screening

- Known hypersensitivity to any component of recombinant protein production by Chinese
Hamster Ovary (CHO) cells

- Participant has been exposed to an IP or investigational device in another clinical
study within 4 weeks prior to IP administration, or is scheduled to participate in
another clinical study involving an IP or investigational device during the course of
this study