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First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Sponsor: Adcendo ApS
Summary
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2025-06-05
Completion Date
2029-02-27
Last Updated
2026-01-28
Healthy Volunteers
No
Interventions
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.
Locations (8)
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