NCT06797999

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Adcendo ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.

Conditions

• Metastatic Soft Tissue Sarcoma
• Unresectable Soft Tissue Sarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-05
• Primary completion: 2029-02-27
• Completion: 2029-02-27
• First posted: 2025-01-29
• Last updated: 2026-01-28

Locations

8 sites across 5 countries: United States, Belgium, France, Germany, United Kingdom

Regulatory

• FDA-regulated drug study