Testing a New Chemo and RNA Therapy Combination

DataBase Center for Life Science; Wikimedia Commons

Could a drug that works against immunosuppressive proteins form an effective combination with standard chemotherapy for advanced or metastatic pancreatic cancer?

After promising results as a solo therapy in phase I trials, researchers have launched a phase IIb/III study to see how this new drug performs in combination with the modified FOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) chemotherapy regimen, possibly enhancing the effects of the standard treatment.

What Is OT-101?

The transforming growth factor-beta (TGF-β for short) is a protein that plays a role in many cellular activities. In cancer tissue, its atypical activation plays a key role in evading immune surveillance and contributes to tumor growth and spread. High expression levels of TGF-β are associated with poor outcomes in pancreatic cancer patients.

OT-101 is a new drug that binds to the human TGF-β2 messenger RNA, blocking the expression of the TGF-β2 protein. Early studies have shown that OT-101 modulates the immunosuppressive actions of TGF-β2, lifting the TGF-β cloaking effect and allowing innate or therapeutic immunity to attack pancreatic cancer cells.

How the Trial Works

This trial will compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX to treatment with mFOLFIRINOX alone, in patients with advanced and unresectable or metastatic pancreatic cancer. The study is looking at overall survival, as well as progression-free survival and the tumor response to the combination.

To participate patients must have advanced and unresectable or metastatic pancreatic cancer. Patients whose cancer has progressed after initial treatment may also join the trial. Those accepted in the trial will be randomized into two arms. One group will receive OT-101 and mFOLFIRINOX in 14-day cycles for up to 12 cycles or 24 weeks; the other will receive only mFOLFIRINOX.

We encourage you to consult your physicians for clinical trials that may be right for you. The website ClinicalTrials.gov provides more details about this trial as well as many others. You can visit the EmergingMed Trial Finder for a list of all active pancreatic cancer clinical trials.

What new treatments and clinical trials are available to me?

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