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

Inclusion Criteria:

1. ≥ 18 years of age

2. Histologically confirmed STS with metastatic and/or unresectable disease (notamenable to treatment with curative intent).

3. Prior treatment with at least one but no more than two lines of cytotoxic systemictherapy 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 periodand for at least 4 months after the last infusion of study treatment, and refrainfrom donating sperm during this period. Male patients with a pregnant partner mustpractice 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 ofchildbearing potential (WOCBP), or agrees to follow the contraceptive guidanceduring the treatment period and for at least 7 months after last infusion of studytreatment.

Exclusion Criteria:

1. Patients who have had systemic anticancer therapy, including any investigationalagent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatmentadministration.

2. Primary brain malignancy or known, untreated central nervous system (CNS) orleptomeningeal 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-inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chestcomputed tomography (CT) scan at screening.