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

The U.S. Food and Drug Administration (FDA) has granted fast track designation to ADCE-D01 for the treatment of soft tissue sarcoma, according to a news release from Adcendo ApS.

"With this fast track designation, the development of ADCE-D01 will now benefit from more frequent interactions with the FDA,” Dr. Victoria Marsh, global head of Regulatory at Adcendo, said in the news release. “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.”

ADCE-D01 is being studied in the ADCElerate1 clinical trial, a first-in-human phase 1/2 study evaluating the drug as a monotherapy for patients with metastatic or unresectable soft tissue sarcoma. The trial aims to assess the safety and tolerability of ADCE-D01, as well as its pharmacokinetics and early signs of effectiveness. Recruitment is underway in the United States and Europe.

ADCE-D01 is a new type of targeted treatment designed to attach to a protein called uPARAP, which is often found in high amounts in certain cancers like sarcomas. Once attached, it delivers medicine directly to the cancer cells to help stop them from growing. In early laboratory studies, ADCE-D01 showed strong tumor-fighting effects and was well tolerated in animals, suggesting it may be safe for further testing in people.

"This fast track designation is an important recognition of the potential of our uPARAP-targeting drug candidate and marks another meaningful milestone for Adcendo,” Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said in the 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."

Fast track is a program from the FDA that helps speed up the development and review of new treatments for serious conditions with limited options. When a drug receives fast track designation, the company can communicate more often with the FDA and submit parts of its application as they’re ready instead of waiting until everything is complete. This process can also make the drug eligible for accelerated approval or priority review if certain requirements are met.

More Trial Information in Soft Tissue Carcinoma

Researchers are first measuring the safest dose of ADCE-D01 and tracking side effects to understand how well patients tolerate it. They’ll also study how the drug moves through the body and measure early signs of effectiveness, such as how many patients see their tumors shrink, how long responses last, and how long the cancer stays under control. The study is expected to take about 18 months to complete after enrollment.

To join the study, patients must be at least 18 years old with confirmed soft tissue sarcoma that has spread or cannot be removed with surgery. They must have already received one or two rounds of chemotherapy for advanced disease, have measurable cancer, be in good physical condition, and have a life expectancy of at least three months. Both men and women must follow specific birth control guidelines during and after treatment.

Patients cannot join if they recently had cancer treatment, have active brain or nervous system involvement, serious heart disease, active HIV or hepatitis B infection, or certain lung conditions seen on scans.

The ADCElerate1 study is taking place at eight locations across the United States and Europe. In the U.S., sites include the University of Colorado in Aurora; the University of Miami’s Sylvester Comprehensive Cancer Center in Florida; Memorial Sloan Kettering Cancer Center in New York; and MD Anderson Cancer Center in Houston, Texas.

International sites include hospitals in Leuven, Belgium; Lyon, France; Essen, Germany; and London, United Kingdom. Some sites are currently recruiting participants, while others are preparing to open enrollment.

References

1. “Adcendo ApS Announces FDA Fast Track Designation Granted to ADCE-D01 for the Treatment of Soft Tissue Sarcoma.” by Adcendo. News release; Oct. 9, 2025.
2. “First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (ADCElerate1).” ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06797999

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