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

Launched by ADCENDO APS · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ADCE-D01 for patients with advanced soft tissue sarcoma, a type of cancer that can spread to other parts of the body and may not be treatable with surgery. The main goals of the study are to find out how safe the treatment is, how well it works, and how well patients can tolerate it. The trial is currently not recruiting participants, but it is open to adults aged 18 and older who have already tried at least one but no more than two other cancer treatments. To be eligible, patients should have a specific type of soft tissue sarcoma that cannot be removed with surgery and meet other health criteria.

If you join this study, you will receive the new treatment and will be closely monitored by healthcare professionals throughout the process. It's important to note that there are some restrictions, such as not having certain other health conditions or recent cancer treatments. Participants will need to agree to follow specific guidelines regarding contraception to ensure safety during the trial. Overall, this study aims to provide valuable information that could help improve treatment options for people with soft tissue sarcoma in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.