First-In-Human Study Of ADCE-D01 In Soft Tissue Sarcoma (ADCElerate1)
Trial ID: NCT06797999
Phase: Phase 1/2
Status: Recruiting
Last Update Posted: January 2026
Eligibility: Adults aged 18 and older with metastatic and/or unresectable soft tissue sarcoma, including synovial sarcoma, who have received at least one but no more than two prior lines of chemotherapy and have measurable disease.
Overview: This first-in-human Phase 1/2 trial evaluates ADCE-D01, an antibody-drug conjugate (ADC) that combines an antibody targeting the uPARAP protein found on sarcoma cells with a topoisomerase I inhibitor designed to kill those cells. ADCE-D01 is given as a weekly intravenous infusion. The trial begins with dose escalation to establish safety and the recommended dose, followed by an expansion phase to evaluate anti-tumor activity including response rate, duration of response, and progression-free survival.
Preliminary Effectiveness: As an early-stage Phase 1/2 trial, no results have been posted to ClinicalTrials.gov at this time. The study aims to evaluate response rate, duration of response, progression-free survival, and clinical benefit rate.
Study Contact: Adcendo ApS
- René Smrčka: rene.smrcka@adcendo.com / +45 3144 0653
- Margaret McNaull: margaret.mcnaull@adcendo.com / +44 7818 457619
Treatment Centers: USA, Belgium, France, Germany, UK