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

Eligibility Criteria

• 1. ≥ 18 years of age
• 2. Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
• 3. Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
• 4. Measurable disease as per RECIST v 1.1.
• 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 6. Life expectancy of at least 3 months.
• 7. 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.
• 8. 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.
• 1. 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.
• 2. Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
• 3. Clinically significant cardiovascular disease
• 4. Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.
• 5. Current active liver disease due to hepatitis B
• 6. 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.