ADCE-D01 Earns FDA Fast Track Designation in Soft Tissue Sarcoma

The FDA has granted fast track designation to ADCE-D01, an investigational antibody drug conjugate (ADC), as a treatment for those with soft tissue sarcoma (STS), according to a press release from the developer, Adcendo ApS.¹

Developers engineered ADCE-D01 to target the urokinase plasminogen activator receptor-associated protein (uPARAP) via a topoisomerase I inhibitor payload, P1021. Investigators noted that uPARAP is overexpressed in sarcomas and other tumors of mesenchymal origin. Additionally, previous preclinical data showed that ADCE-D01 produced strong activity in a variety of mesenchymal tumor models, including STS, without evidence of target-specific toxicity.

“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 at Adcendo, stated in the press release.¹ “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.”

Investigators are currently evaluating ADCE-D01 monotherapy among patients with metastatic and/or unresectable STS as part of the first-in-human, multicenter, open-label, dose-escalation and dose-expansion phase 1/2 ADCElerate1 trial (NCT06797999). The trial’s primary end points are the maximum tolerated dose and recommended phase 2 dose of ADCE-D01 as well as safety and tolerability.² Secondary end points include objective response rate, duration of response, progression-free survival, clinical benefit rate, and time to response.

Patients 18 years and older with histologically confirmed metastatic and/or unresectable STS, prior treatment with 1 or 2 lines of cytotoxic systemic therapy for metastatic and/or unresectable disease, and measurable disease per RECIST v1.1 guidelines are eligible for enrollment on the trial. Other eligibility criteria include having an ECOG performance status of 0 or 1 and a minimum life expectancy of 3 months.

Those with prior systemic anticancer therapy, including any investigational agent, within 4 weeks or 5 half-lives of beginning study therapy are ineligible to enroll on the trial. Patients are also unable to enroll if they have primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases; clinically significant cardiovascular disease; acute infection with HIV 1 or HIV 2, current active liver disease due to hepatitis B; and a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-related pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per CT imaging at screening.

“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 Adcendo, stated in the press 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.”

In June 2025, developers announced that the first patient had successfully undergone dosing with ADCE-D01 as part of the ADCElerate1 trial.³ A press release noted that the patient received treatment at Memorial Sloan Kettering Cancer Center.

“We are pleased to be working with Adcendo to develop ADCE-D01 for the many advanced [patients with] STS who currently have limited treatment options,” Robert Maki, MD, PhD, a sarcoma medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center, stated at the time the first patient began study treatment.³ “ADCs have already made a significant impact across the therapeutic landscape, and we are pleased to be able to bring this exciting treatment modality to our sarcoma patients.”

References

1. Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma. News release. Adcendo ApS. October 9, 2025. Accessed October 10, 2025. https://tinyurl.com/4tv95k3v
2. First-in-human study of ADCE-D01 in soft tissue sarcoma (ADCElerate1). ClinicalTrials.gov. Updated June 29, 2025. Accessed October 10, 2025. https://tinyurl.com/m59htkyt
3. Adcendo ApS announces first patient dosed in phase I/II ADCElerate1 trial of ADCE-D01. News release. Adcendo ApS. June 10, 2025. Accessed October 10, 2025. https://tinyurl.com/3rhss8sb