First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.

Inclusion criteria

• ≥ 18 years of age
• Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
• Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
• Measurable disease as per RECIST v 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• 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 is eligible if not pregnant, not breast feeding, and 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

• Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
• Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
• Clinically significant cardiovascular disease
• Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
• Current active liver disease due to hepatitis B
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.