RecruitingPhase 1Phase 2NCT06861452

Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma

RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study


Sponsor

EIR Biotherapies s.r.l.

Enrollment

9 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

RR001, a cell-based gene therapy administered following chemotherapy cycles for the treatment of patients with locally advanced pancreatic cancer. Phase I /IIa clinical trial (open label and non-randomized) to test the effects (safety \& efficacy) of increasing doses of RR001


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety and dosing of a new treatment called RR001 given by injection directly into a tumor, combined with chemotherapy, for people with locally advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You have confirmed pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) that is locally advanced and cannot be surgically removed - There is no evidence of spread to other organs - You have at least one tumor lesion of 3.5 cm or smaller that can be reached by ultrasound-guided injection - You are in good enough health to receive chemotherapy (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has already spread beyond the pancreas to distant organs - Your tumor is too large or not accessible for direct injection - You are in poor overall health 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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Interventions

DRUGRR001

RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)


Locations(1)

Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena

Modena, Italy, Italy

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NCT06861452


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