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
-To determine the MTD/maximum administered dose and RP2DS of ADCE-D01. -To assess the safety and tolerability of ADCE-D01.
Why this Research Matters
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
Who can Participate
Inclusion: -Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent). -Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease. Exclusion: -Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement. Clinically significant cardiovascular disease -Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement. Clinically significant cardiovascular disease Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Protocol Number: 24-2281
More information available at ClinicalTrials.gov: NCT06797999
Meet the Team
Principal Investigator