First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (ADCElerate 1)

• Research type

  Research Study

• Full title

  A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients with Metastatic and/or Unresectable Soft Tissue Sarcoma

• IRAS ID

  1013206

• Contact name

  Victoria Marsh

• Contact email

  victoria.marsh@adcendo.com

• Sponsor organisation

  Adcendo ApS

• Clinicaltrials.gov Identifier

  NCT06797999

• Research summary

  This study is designed to test a new investigational drug called ADCE-D01 for the treatment in soft tissue sarcoma.

  ADCE-D01 is an antibody that is attached to a cytotoxic chemotherapy drug called an antibody-drug conjugate. Antibodies target foreign proteins such as bacteria or other foreign substances and can also be created to specifically target the surface of cancer cells. The antibody in ADCE-D01 has been designed to recognise a specific protein which can be found on the surface of certain types of cells in the body, in particular cancer cells. ADCE-D01 works by the antibody finding the cancer cells that express this protein, binding to these cancer cells, and then releasing the chemotherapy drug into the cancer cell to kill it.
  Antibody-drug conjugates are a relatively new form of treatment. Some antibody-drug conjugates have already been studied for other types of cancers, and a small number have been approved to treat cancers such as lung and breast cancer. This is the first time the study drug ADCE-D01, is being used in humans. Previous experience with this study drug has been limited to testing in animals, where it did shrink tumours.

  This study is being conducted in 2 Phases:
  Phase 1a: where the dose is slowly increased from one group of participants to the next (dose escalation period)
  Phase 1b: where 2 different doses or schedules of ADCE-D01 are compared with each other (dose confirmation period)
  Phase 2: where a dose confirming will be conducted

  Participants will receive ADCE-D01 via intravenous infusion on Day 1, 8 and 15 or Days 1 and 15 in treatment cycles of 28 days until relapse/disease progression, experience side effects that make it necessary to stop receiving ADCE-D01, start a new anti-cancer treatment, or consent withdrawal. Study duration is approximately 18 months in Phase 1.

  Approximately, 280 participants will take part at hospitals in the UK, Belgium, Germany, France and USA.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  26/WM/0078

• Date of REC Opinion

  18 May 2026

• REC opinion

  Further Information Favourable Opinion