The study spans multiple gastrointestinal tumour indications. Credit: crystal light/Shutterstock.

Oncolytics Biotech has dosed the first patient with a combination therapy of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) for metastatic pancreatic cancer as part of the Gastrointestinal tumOrs trials.

The trial is exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1 (GOBLET) study cohort.

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The GOBLET study is a phase I/II multiple indication study conducted in advanced or metastatic gastrointestinal tumors.

Being managed by AIO-Studien-gGmbH, the study is exploring pelareorep-based combinations and is being conducted at 17 sites in Germany.

Objective response rate (ORR) and safety are the co-primary endpoints of the cohort.

The new cohort will focus on patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), evaluating the combination of pelareorep and mFOLFIRINOX with or without atezolizumab.

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It is supported by the $5m Pancreatic Cancer Action Network Therapeutic Accelerator Award.

Oncolytics Biotech chief medical officer Thomas Heineman said: “Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we are excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration programme for the company.

“The combination of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel in pancreatic cancer patients more than doubled tumour response rates compared to earlier trials of chemotherapy alone.”

The mFOLFIRINOX cohort of the GOBLET study will include a safety run-in with three patients to assess the tolerability of each treatment arm – pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX.

The study’s co-primary endpoints are ORR and/or disease control rate evaluated at week 16 and safety.

Its key secondary and exploratory endpoints cover additional efficacy assessments and potential biomarkers evaluation.

In stage 1 of the study, 15 evaluable patients will be randomised to each arm. If successful, the trial may expand to stage 2, adding 17 more patients per arm.

Each cohort within the GOBLET study has the potential to progress to stage 2, subject to meeting pre-specified efficacy criteria, allowing for the expansion of patient enrolment.