Tests ADCE-D01 in adults with advanced soft tissue sarcoma
Tests ADCE-D01 for safety and effect in adults with advanced soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Key facts
- Where
- Aurora, Houston, Miami, and New York, United StatesSee the 4 sites
- Phase
- Phase 1/2
Where in United States
- University of Colorado DenverAurora, United StatesTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- University of Miami - Sylvester Comprehensive Cancer CenterMiami, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Adcendo ApS
- Trial code
- NCT06797999EU 2024-516900-41-00
- Record updated
- 11 September 2026
- Original description
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.Read full original descriptionShow less
A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Inclusion: ≥ 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: 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.