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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.