First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of solid tumor
* Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
* Radiologically or clinically determined progressive disease during or after most recent line of therapy
* Measurable disease per RECIST 1.1
* ECOG performance status of 0 or 1
* Adequate hematological and biochemical parameters
* A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
* A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment

Exclusion Criteria

* Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
* Prior treatment with an ADC containing a topoisomerase I inhibitor payload
* Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
* Other malignancy
* Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
* Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1
* Clinically significant cardiovascular disease
* Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
* Current active liver disease due to hepatitis B or hepatitis C
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis