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

Recruiting now · Phase 1/Phase 2

Conditions studied: Metastatic Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma

In brief

The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.

Key facts

Study ID: NCT06797999
Run by: Adcendo ApS
People needed: 270
Starts: 2025-06-05
Expected to finish: 2029-02-27
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥ 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.

You may not qualify if…

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.

Where it is running

University of Colorado Denver — Aurora, Colorado, United States (enrolling)
University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
University Of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg — Leuven, Belgium (enrolling)
Centre Léon Bérard — Lyon, France (enrolling)
Universitätsklinikum Essen West German Tumor Center — Essen, Germany (enrolling)
Royal Marsden — London, United Kingdom

Full record on ClinicalTrials.gov

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