A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

What is the Purpose of this Study?

We are doing this study to find the most effective, safe dose of an experimental drug called disitamab vedotin (the study drug). We want to know how well this study drug works in people who have advanced or metastatic solid tumors.

What is the Condition Being Studied?

Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have unresectable, recurrent tumor(s) or metastatic stage disease
  • Have documented HER2 expression 1+, 2+, or 3+ of tumor
  • Have not had a prior treatment with an MMAE-containing agent
  • Have not had a previous treatment with HER2-directed ADCs

For more information about who can join this study, please contact the study team at 919-684-6342.

Age Group
Adults

What is Involved?

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:

  • Have a physical exam
  • Have a heart scan (ECG)
  • Have blood draws
  • Have a tumor biopsy

We will test your tumor tissue during the screening period to see if HER2 can be detected in the cancer cells.

If you are eligible based on screening, you will begin to receive the study drug into a vein in your arm (intravenous/IV) every 2 weeks. You will get the study drug until the study doctor decides it is no longer necessary or it is not offering you any benefit.

At various visits throughout the study, you will have blood tests, MRI or CT scans, ECGs, and tumor biopsies taken.

Study Details

Full Title
A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
Principal Investigator
Associate Professor of Medicine
Protocol Number
IRB: PRO00114222
NCT: NCT06003231
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL