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

Conditions

Ductal adenocarcinoma of pancreas, Locally advanced, non-resectable pancreatic adenocarcinoma

Brief summary

To investigate the safety of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX, To establish the MTD and RP2D of intratumoral injections of RR001 after three dose levels delivery in combination with standard of care therapy

Detailed description

To investigate the feasibility of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX, Antitumor activity: Target tumor response will be assessed by objective radiologic assessment using RECIST 1.1 criteria, Response rate: the overall response rates (ORR) for objective response (complete, partial responses, stable disease, progressive disease) will be assessed by objective radiographic assessment using RECIST 1.1 criteria, Percentage of patients successfully undergoing to surgery and percentage of pathological resection (R0 vs. R1 vs. R2), Time to disease progression (TTP), Overall survival (OS), Tumor markers in serum (CEA, CA19.9 if present at the diagnosis), Quality of life by scoring of quality of life according to the EORTC QLQ-C30 and QLQ-PAN26, Progression free survival (PFS)

Related papers

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Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGGemsol 40 mg/ml concentrato per soluzione per infusione

DRUGRR001

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To investigate the safety of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX, To establish the MTD and RP2D of intratumoral injections of RR001 after three dose levels delivery in combination with standard of care therapy	—

Secondary

Measure	Time frame
To investigate the feasibility of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX, Antitumor activity: Target tumor response will be assessed by objective radiologic assessment using RECIST 1.1 criteria, Response rate: the overall response rates (ORR) for objective response (complete, partial responses, stable disease, progressive disease) will be assessed by objective radiographic assessment using RECIST 1.1 criteria, Percentage of patients successfully undergoing to surgery and percentage of pathological resection (R0 vs. R1 vs. R2), Time to disease progression (TTP), Overall survival (OS), Tumor markers in serum (CEA, CA19.9 if present at the diagnosis), Quality of life by scoring of quality of life according to the EORTC QLQ-C30 and QLQ-PAN26, Progression free survival (PFS)	—

Measure

Time frame

To investigate the feasibility of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX, Antitumor activity: Target tumor response will be assessed by objective radiologic assessment using RECIST 1.1 criteria, Response rate: the overall response rates (ORR) for objective response (complete, partial responses, stable disease, progressive disease) will be assessed by objective radiographic assessment using RECIST 1.1 criteria, Percentage of patients successfully undergoing to surgery and percentage of pathological resection (R0 vs. R1 vs. R2), Time to disease progression (TTP), Overall survival (OS), Tumor markers in serum (CEA, CA19.9 if present at the diagnosis), Quality of life by scoring of quality of life according to the EORTC QLQ-C30 and QLQ-PAN26, Progression free survival (PFS)

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Countries

Italy

Outcome results

None listed