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RECRUITING
NCT06797999
PHASE1/PHASE2

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

Sponsor: Adcendo ApS

View on ClinicalTrials.gov

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

BIOLOGICAL

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