RecruitingPhase 1Phase 2NCT06797999

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

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


Sponsor

Adcendo ApS

Enrollment

270 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new investigational drug called ADCE-D01 in patients with soft tissue sarcoma (a rare type of cancer affecting muscles, fat, nerves, or connective tissue) that has spread or cannot be removed by surgery. The study will assess how safe the drug is and how well the body handles it. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of soft tissue sarcoma that has spread or cannot be surgically removed - You have received 1 or 2 previous lines of chemotherapy for your disease - Your cancer is measurable on imaging - You are in reasonably good health (ECOG 0-1) and have a life expectancy of at least 3 months - You are willing to use contraception during and after the study **You may NOT be eligible if...** - You have received more than 2 prior systemic treatments for metastatic/unresectable disease - You have poor organ function or significant other medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAntibody-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

View Full Details on ClinicalTrials.gov

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NCT06797999


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