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Medicine Matters oncology

I'm Dr. Jame Abraham. I'm the chair of hematology oncology here at Cleveland Clinic, Cleveland, Ohio.

So this is an antibody drug conjugate. It has been found to be active in metastatic breast cancer. So LIV-1, again, it's a transmembrane protein that has been found in breast cancer, and then depending upon the study, it's present in about 70% to 90% of breast cancer.

So when LIV-1 is present, that's been associated with a rapid progression to metastasis. And it's associated with lymph node involvement in breast cancer. So it's potentially-- it's a poor prognostic factor which can lead to rapid progression of the disease. So this particular drug-- this particular antibody for a conjugate is against this transmembrane protein.

So our particular study, the phase 1, open label dose escalation and expansion study in metastatic breast cancer, and the dosing of this particular study, and in this particular phase 1, we are trying a weekly regimen. So it's a weekly regimen. They're trying to find what's the appropriate dose in this setting.

So the aim of the study is to look at the safety and tolerability of this once-a-week dosing of this LIV-1 antibody in patients with metastatic breast cancer, and especially endocrine, or hormone-resistant, metastatic breast cancer and HER2-negative breast cancer and triple-negative breast cancer. That's what we're looking for. And the other aims of the studies are looking at the maximum tolerated dose, and then, secondary objectives are to assess the anti-tumor activity and then, of course, we'll do the follow-up [INAUDIBLE] and then other correlated studies. And what we're doing is including patients, as I said, triple-negative and hormone receptor-positive metastatic breast cancer. And then, so far, we've been really-- we can say that it's fairly safe, and we continue to escalate the dose.

The study is done across 34 different sites. And then, we are hoping that we will complete the study by March 2022. That's our hope. So there are different antibody drug conjugates FDA-approved.

And again, we really think that this will be a potentially active agent. Again, we need to complete the phase one and then go to the phase two to really understand the efficacy of the study.