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

NCT06797999 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-01-28

No results posted yet for this study

Summary

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

Conditions

  • Metastatic Soft Tissue Sarcoma
  • Unresectable Soft Tissue Sarcoma

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.

Sponsors & Collaborators

  • Adcendo ApS

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2029-02-27
Completion
2029-02-27
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797999 on ClinicalTrials.gov