FDA Fast Tracks ADCE-D01 for Soft Tissue Sarcoma Treatment

The FDA has granted fast track designation to the antibody-drug conjugate (ADC) ADCE-D01 for the treatment of soft tissue sarcoma (STS).¹

Although STS is a rare malignancy that accounts for no more than 1% of all malignant tumors, it is one of the most common rare cancers, with an incidence rate that has increased in the past 30 years.² Coupled with a 10-year survival rate of less than 50%,² these data signal an alarming trend that constitute a critical unmet medical need.

The FDA fast track designation is granted to novel agents that fill serious unmet medical needs, facilitating development and expediting review.^1,3 With this designation, Adcendo, the sponsor, will have the opportunity to interact more frequently with the FDA, gain eligibility for accelerated approval and priority review if criteria are met, and submit a biologics license application or new drug application under rolling review.

“With this [f]ast [t]rack designation, the development of ADCE-D01 will now benefit from more frequent interactions with the FDA. 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,” said Victoria Marsh, PhD, global regulatory head at Adcendo, in a press release.¹

The agent is currently being investigated in the actively recruiting phase 1/2 ADCElerate1 trial (NCT06797999) in patients with metastatic and/or unresectable STS.⁴

Mechanistic Rationale for ADCE-D01 in STS

ADCE-D01 is a first-in-class ADC that targets urokinase plasminogen activator receptor-associated protein (uPARAP), a novel endocytic target overexpressed in mesenchymal tumors such as STS, conjugated to the topoisomerase I inhibitor payload P1021.

The fast track designation is supported by preclinical evidence of antitumor activity by ADCE-D01 in several STS tumor models. In addition, toxicology studies have demonstrated a favorable safety and tolerability profile, with no evidence of target-specific toxicities.

“This [f]ast [t]rack designation is an important recognition of the potential of our uPARAP-targeting drug candidate and marks another meaningful milestone for Adcendo. 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,” added Lone Ottesen, MD, PhD, chief medical officer of Adcendo, in the press release.¹

The open-label, multicenter phase 1/2 clinical trial is a first-in-human study evaluating ADCE-D01 as monotherapy in adult patients with histologically confirmed metastatic and/or unresectable STS.² The study is designed as a dose-escalation and dose-expansion study, with primary objectives of evaluating the safety and tolerability of the agent. Secondary end points being studied include pharmacokinetics and preliminary efficacy.

The study plans to enroll 270 patients in the US and Europe, with an estimated primary completion date of February 2029.

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://tinyurl.com/45jweh9e

2. Chen C, Wang C, Li S, et al. Global, regional, and national burden of soft tissue and extraosseous sarcomas from 1990 to 2021. Prev Med Rep. 2024;47:102903-102903. doi:10.1016/j.pmedr.2024.102903

3. Fast track. FDA. Updated August 13, 2024. Accessed October 9, 2025. https://tinyurl.com/ms2695jn

4. 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