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

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

Niharika

Mettu

Protocol Number

PRO00114222

NCT ID

NCT06003231

Phase

Enrollment Status

Open to Enrollment

ClinicalTrials.gov