Patient Enrollment Begins for Trial Assessing Novel Treatment Combo in Pancreatic Cancer

The study authors plan to enroll 32 patients with advanced pancreatic cancer into the trial to assess the efficacy and safety of an experimental treatment combination.

Actuate Therapeutics recently announced the enrollment of the first patient onto the phase 2 RiLEY (NCT05239182) trial, a study which is investigating the frontline use of elraglusib plus retifanlimab combined with gemcitabine/nab-paclitaxel in patients with advanced pancreatic cancer.

The plan, according to a press release issued by Actuate, is to enroll 32 patients onto the trial.

“We are very excited to launch this first study of elraglusib combined with retifanlimab as a potentially synergistic immune-modulatory approach for patients with advanced pancreatic cancer,” lead study author Dr. Anwaar Saeed, lead investigator in the Gastrointestinal Oncology and Early Phase Developmental Therapeutics Program at University of Kansas Cancer Center, said in the release.

“The first generation of immune checkpoint (PD-1, PDL-1, CTLA-4) inhibitors including retifanlimab address a key subset of the cancer-created blockade of anti-cancer effector cells in our immune system,” she continued. “We are now beginning to study novel therapies that will modulate other checkpoints and thus be synergistic with the current agents — elraglusib is such an agent. We are very focused on elraglusib in this context as the increasing data on its role as an immune-modulator, including its ability to stimulate NK/T-cell anticancer effector functions, has been generated against a background of it showing meaningful clinical activity in a spectrum of cancers, particularly advanced pancreatic cancer.”

Measuring the disease control rate (defined at the time of enrollment until the date of first documented disease progression or date of death from any cause, whichever is first, assessed up to 60 months) following treatment with the regimen is the main goal of the study.

The authors also plan to analyze both the overall response rate (the proportion of patients whose tumor was destroyed or significantly reduced), as well as the presence of treatment-related side effects.

Patients enrolled onto the trial must be aged 18 years or older, be confirmed to have advanced, recurrent or metastatic disease without receiving prior treatment in this particular setting. Moreover, patients need to be deemed to have adequate bone marrow, liver and kidney functions.

“The pre-clinical data generated with elraglusib, as a single agent and in combination with checkpoint inhibitors, along with clinical data supporting its immunomodulatory activity is increasingly compelling,” said Actuate’s President and CEO Daniel M. Schmitt in the release. “In addition to elraglusib’s established anticancer activity via direct cytotoxicity and reversal of chemoresistance, its immunomodulatory actions may be particularly synergistic with those of anti-PD-1 checkpoint inhibitors. Driven by these synergistic mechanisms of action, we are very excited to include this clinical study in our program for patients with pancreatic cancer and as a template for studies of immunomodulatory combinations for patients with other refractory cancer types.”

Actuate also noted that it has started conducting an international trial assessing gemcitabine/nab-paclitaxel versus elraglusib in combination with gemcitabine/nab-paclitaxel, in patients with advanced pancreatic cancer in the first-line setting.

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