FDA Grants Fast Track Designation to ADCE-D01 for Soft Tissue Sarcoma

The FDA has granted fast track designation to the first-in-class urokinase plasminogen activator receptor–associated protein (uPARAP)–targeted antibody-drug conjugate (ADC) ADCE-D01 for the treatment of patients with soft tissue sarcoma.1

ADCE-D01, which also features a topoisomerase I inhibitor payload, has demonstrated preclinical antitumor activity across a range of models of mesenchymal tumors, including soft tissue sarcomas, which are associated with overexpression of uPARAP. The agent also displayed preclinical tolerability in non-human primate toxicology studies, with no evidence of uPARAP-specific toxicity.

The ADC is currently being evaluated in patients with soft tissue sarcoma in the phase 1/2 ADCElerate1 trial (NCT06797999).

“This fast track designation is an important recognition of the potential of our uPARAP-targeting drug candidate and marks another meaningful milestone for Adcendo,” Lone Ottesen, MD, PhD, chief medical officer of Adcendo, stated in a news release. “We are committed to further advancing ADCE-D01 and believe that our uPARAP-targeting approach has the potential to transform the sarcoma treatment landscape and overcome the limitations experienced with existing therapies.”

What Is the Design of the ADCElerate1 Trial Evaluating ADCE-DO1 in Soft Tissue Sarcoma?

The first-in-human, multicenter, open-label, dose-escalation and -expansion ADCElerate1 trial is enrolling patients at least 18 years of age with histologically confirmed metastatic and/or unresectable soft tissue sarcoma that is not amenable to curative-intent treatment who received 1 to 2 prior lines of systemic therapy in the metastatic/unresectable setting.2

Other key inclusion criteria comprise measurable disease per RECIST 1.1, criteria, an ECOG performance status of 0 or 1, and a life expectancy of at least 3 months. Investigators are excluding patients who received systemic anticancer therapy within 4 weeks or 5 half-lives of the first study dose; those with primary brain malignancies or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement; patients with clinically significant cardiovascular disease; those with acute HIV 1 or 2; patients with current active liver disease due to hepatitis B; and those with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.

All enrolled patients are receiving ADCE-D01 as a single agent. The study’s primary end points are to determine the maximum tolerated dose/maximum administered dose and recommended phase 2 dose; and safety and tolerability. Regarding safety and tolerability, investigators are assessing the incidence and severity of treatment-emergent adverse effects, along with how TEAEs associate with treatment interruptions, dose reductions, and treatment discontinuation. Secondary end points include pharmacokinetics, objective response rate, duration of response, progression-free survival, clinical benefit rate, and time to response.

The ADCElerate1 trial initiated enrollment in June 2025 and has a target enrollment of approximately 270 patients between the dose-escalation and -expansion portions of the study

“With this fast track designation the development of ADCE-D01 will now benefit from more frequent interactions with the FDA,” Victoria Marsh, PhD, global head of Regulatory at Adcendo, added in a news release.1 “Increased FDA engagement will support and expedite the future regulatory review of ADCE-D01 with the aim of making ADCE-D01 available to patients sooner.”

References

1. Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma. News release. Adcendo. October 9, 2025. Accessed October 9, 2025. https://adcendo.com/adcendo-aps-announces-fda-fast-track-designation-granted-to-adce-d01-for-the-treatment-of-soft-tissue-sarcoma/
2. First-in-human study of ADCE-D01 in soft tissue sarcoma (ADCElerate1). ClinicalTrials.gov. Updated June 29, 2025. Accessed October 9, 2025. https://clinicaltrials.gov/study/NCT06797999