The companies aim to begin trial enrolment by the end of 2023. Credit: Mai.Chayakorn / Shutterstock.

The Phase Ib/II clinical trial of AstraZeneca’s Imfinzi (durvalumab) and AIM ImmunoTech’s Ampligen (rintatolimod) combination therapy for the treatment of metastatic pancreatic ductal adenocarcinoma has received the required approvals to initiate the study in the Netherlands.

The trial is part of an externally sponsored collaborative clinical research agreement between AstraZeneca, Aim ImmunoTech, and Erasmus Medical Centre.

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Erasmus MC secured regulatory approvals from the clinical trials review authority in the Netherlands (Central Committee on Research Involving Human Subjects) and the local governing ethics board (Medical Ethics Review Committee Erasmus MC).

The companies aim to begin trial enrolment by the end of 2023, with an expected participant population of 9-18 years and 13-25 years subjects in Phase Ib and Phase II, respectively.

AstraZeneca currently has a drug in the market for metastatic adenocarcinoma of the pancreas and metastatic pancreatic cancer called Lynparza (Olaparib). GlobalData forecasts Lynparaza to perform well in the future, with its global sales rising to over $6bn in 2027.

GlobalData is the parent company of Clinical Trials Arena.

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Imfinzi is being evaluated for multiple indications, including non-small cell lung cancer and epithelial ovarian cancer. Ampligen is currently under investigation for long Covid.

Expected trial design

The open-label, single-centre Phase Ib/II DURIPANC study is designed to explore the combined effect of Imfinzi, an anti-programmed cell death protein 1 (PD1) immune checkpoint inhibitor, and Ampligen, a toll-like receptor 3 (TLR3) agonist, in the treatment of metastatic pancreatic ductal adenocarcinoma.

Phase Ib’s primary objective is to evaluate the safety of the combination therapy, while Phase II will primarily aim to determine the clinical efficacy of the therapy.

The patients will be given the first dose of Imfinzi during the second week after receiving two doses of Ampligen during the first week.

The Ampligen will continue at two doses per week for six weeks. Imfinzi will be administered every four weeks till 48 weeks or until confirmed disease progression according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1) unless discontinued for a different reason.