RecruitingPhase 2Phase 3NCT06079346

A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

A Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

Sponsor

Oncotelic Inc.

Enrollment

455 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

Summary

The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing OT-101 — a drug that targets a protein called TGF-beta2 that helps cancers evade the immune system — combined with a standard chemotherapy regimen called mFOLFIRINOX, for people with advanced or metastatic pancreatic cancer. **You may be eligible if...** - You have been diagnosed with advanced, unresectable (cannot be removed by surgery), or metastatic pancreatic adenocarcinoma, confirmed by tissue testing from the pancreas or another site - You have measurable tumor sites according to standard imaging criteria **You may NOT be eligible if...** - You have a different type of pancreatic cancer - You do not have measurable disease on imaging - You do not meet other medical safety criteria assessed by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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