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Phase 2 Trial to Study Novel Drug in Pretreated Solid Tumors


The first patient was treated in a phase 2 trial assessing the safety and efficacy of navicixizumab, with or without chemotherapy, in colorectal, gastric, ovarian and breast cancer.

A phase 2 trial has initiated evaluating navicixizumab — alone or in combination with chemotherapy — for patients with colorectal cancer or triple-negative breast cancer, according to OncXerna Therapeutics, the manufacturer of the novel drug.

The trial, which is currently open for enrollment in six cancer centers across the United States, will start with two groups. One will be analyzing navicixizumab alone or in combination with irinotecan for patients with colorectal cancer that has failed two lines of prior standard therapy, including Avastin (bevacizumab) or an equivalent antibody. The other will evaluate navicixizumab alone or in combination with paclitaxel for patients with triple-negative breast cancer who received between two and four standard lines of therapy for metastatic disease, including an immune checkpoint inhibitor or Trodelvy (sacituzumab govitecan).

Researchers plan on adding another two groups to the trial in the future — one investigating the drug in as a monotherapy in pretreated, relapsed/refractory ovarian cancer and the other looking at navicixizumab plus paclitaxel in patients with gastric or gastroesophageal cancer that has previously been treated with an immune checkpoint inhibitor.

“We are excited to have this study underway and look forward to evaluating the potential clinical impact of navicixizumab in these settings where patients have limited treatment options and prognosis is poor,” said Dr. Paul Oberstein, director of GI Medical Oncology in the Perlmutter Cancer Center and associate professor of medicine at NYU Langone Health in New York, in a press release.

The main goals of the trial are objective response rate (which measures how much tumors shrink as a result of treatment) and progression-free survival (time from treatment until the disease worsens). Secondary goals of the trial are overall survival (time from treatment until death of any cause), duration of response, safety and tolerability, and the relationship between Xerna TME Panel biomarker subtype and anti-tumor activity of the navicixizumab-containing regimens.

Navicixizumab works by inhibiting CLL4 and VEGF, both of which play roles in the proliferation of cancer cells.

“Aberrant Notch expression is associated with poor prognosis and treatment resistance in many solid tumors, including colorectal cancer and triple-negative breast cancer. Navicixizumab simultaneously targets inhibition of DLL4, a ligand of the Notch pathway, and VEGF, making this a very attractive therapeutic strategy to evaluate,” Oberstein said.

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