Adcendo ApS announces FDA Fast Track Designation granted to ADCE-D01 for the treatment of soft tissue sarcoma

CAR-T Digest - August 2020

09 October 2025: Adcendo ApS announces FDA Fast Track Designation granted to ADCE-D01 for the treatment of soft tissue sarcoma

US FDA has granted Fast Track designation to Adcendo’s ADCE-D01, an antibody-drug conjugate (ADC) targeting uPARAP, intended for treating soft tissue sarcoma (STS)
The Fast Track status will enable closer FDA collaboration, potentially accelerating ADCE-D01’s development and regulatory review to bring it to patients sooner
ADCE-D01 is a first-in-class ADC linking an anti-uPARAP antibody to a Topoisomerase I inhibitor (P1021) payload, designed for tumors of mesenchymal origin
Preclinical studies have previously demonstrated strong anti-tumor activity in various mesenchymal tumor models and good tolerability in non-human primates with no target-related toxicity
The drug is being evaluated in the Phase 1/2 ADCElerate1 trial (NCT06797999) as a monotherapy for metastatic or unresectable STS to assess safety, pharmacokinetics, and preliminary efficacy