A Phase 1-2 Study of ADCE-D01 in People With Advanced Soft Tissue Sarcoma

Share

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

Purpose

Researchers want to find the best dose of ADCE-D01 to treat soft tissue sarcoma. In this study, we treat people with soft tissue sarcoma that is inoperable (cannot be surgically removed) or metastasized (spread).

ADCE-D01 acts like a Trojan horse to kill sarcoma cells. It has two parts. One part sticks to certain proteins on cancer cells and enters the cells. Then the second part, an anti-cancer drug (poison), is released to kill them. ADCE-D01 is given intravenously (by vein). 

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic or inoperable soft tissue sarcoma that keeps growing after 1 or 2 prior types of chemotherapy.
  • Have recovered from the side effects of previous treatments before getting ADCE-D01.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework to take part in the study. 
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Robert Maki’s office at 646-888-5059.

Protocol

25-031

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06797999