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:<ul>
<li>Have unresectable, recurrent tumor(s) or metastatic stage disease</li>
<li>Have documented HER2 expression 1+, 2+, or 3+ of tumor</li>
<li>Have not had a prior treatment with an MMAE-containing agent</li>
<li>Have not had a previous treatment with HER2-directed ADCs</li></ul>
For more information about who can join this study, please contact the study team at 919-684-6342.
<li>Have unresectable, recurrent tumor(s) or metastatic stage disease</li>
<li>Have documented HER2 expression 1+, 2+, or 3+ of tumor</li>
<li>Have not had a prior treatment with an MMAE-containing agent</li>
<li>Have not had a previous treatment with HER2-directed ADCs</li></ul>
For more information about who can join this study, please contact the study team at 919-684-6342.
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:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li></ul>
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.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li></ul>
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
II
Enrollment Status
Open to Enrollment