Three-dimensional culture of human breast cancer cells, with DNA stained blue and a protein in the cell surface membrane stained green. Credit: The National Institutes of Health.

A team of researchers at the University of California (UC) San Diego School of Medicine has initiated a Phase Ib clinical trial to evaluate the safety and tolerability of cirmtuzumab and standard chemotherapy combination for the treatment of metastatic or locally advanced breast cancer.

The trial will enrol up to 15 patients whose cancer cannot be removed surgically in order to administer the combination therapy for a period of six months.

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For the trial, the researchers will combine cirmtuzumab with paclitaxel (Taxol), a chemotherapy medication originally derived from the Pacific yew tree and has been proved to be effective in various types of cancer treatments.

The trial’s co-principal investigator Barbara Parker said: “Our primary objective, of course, is to determine whether the drug combination is safe and tolerable and to measure its anti-tumour activity.

“If it proves safe and shows effectiveness against breast cancer, we can progress to subsequent trials to determine how best to use the drug combination.”

“Our primary objective, of course, is to determine whether the drug combination is safe and tolerable and to measure its anti-tumour activity.”

Earlier this year, UC San Diego School of Medicine researchers commenced a Phase Ib/II clinical trial to investigate the effectiveness of cirmtuzumab in combination with ibrutinib to treat patients with B-cell malignancies, including mantle cell lymphoma (MCL) and chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL).

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The US-based California Institute for Regenerative Medicine (CIRM), along with Oncternal Therapeutics, has sponsored the Phase Ib/II trial, which is currently recruiting patients and is similar to the new Phase Ib trial.

Cirmtuzumab is a new monoclonal antibody developed to target ROR1, a cell surface protein that exists on tumours, but not in normal adult tissues.

It has been developed at UC San Diego, with support from CIRM and CIRM-funded Alpha Clinic at UC San Diego.

According to UC San Diego School of Medicine, breast cancer in both women and men is the most common type of malignancy, with around 270,000 new cases diagnosed every year.