First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
NCT ID: NCT06797999
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
270 participants
INTERVENTIONAL
2025-06-05
2029-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ADCE-D01
ADCE-D01
Antibody-drug conjugate (ADC)
ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker.
Interventions
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Antibody-drug conjugate (ADC)
ADCE-D01 is an antibody-drug conjugate (ADC) composed of an anti-urokinase plasminogen activator receptor-associated protein (uPARAP) antibody, AB-004, conjugated to a topoisomerase I inhibitor, P1021, via a protease cleavage tetra-peptide linker.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Adcendo ApS
INDUSTRY
Responsible Party
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Locations
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University of Colorado Denver
Aurora, Colorado, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Of Texas MD Anderson Cancer Center
Houston, Texas, United States
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
Leuven, , Belgium
Centre Léon Bérard
Lyon, , France
Universitätsklinikum Essen West German Tumor Center
Essen, , Germany
Royal Marsden
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Breelyn Wilky, Dr.
Role: primary
Jonathan Trent, Dr.
Role: primary
Robert Maki, Dr.
Role: primary
Shreyaskumar Patel, Dr.
Role: primary
Patrick Schöffski, Dr.
Role: primary
Jean-Yves Blay, Prof.
Role: primary
Sebastian Bauer, Dr.
Role: primary
Robin Jones, Dr.
Role: primary
Other Identifiers
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2024-516900-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
ADCE-D01-001
Identifier Type: -
Identifier Source: org_study_id
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