This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.
Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.
Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug.
No evidence of distant metastasis.
Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.
Participants who are receiving any other investigational agents.
Participants with known metastatic disease.
History of allergic reactions attributed to gadolinium-based IV contrast.
Parallel
AGuIX
DrugInjected gadolinium-based nanoparticles
Radiotherapy
RadiationStereotactic magnetic resonance-guided adaptive radiation therapy
Maximum tolerated dose (MTD) Phase 1
Evaluated by the occurrence of Dose Limiting Toxicity (DLT) over the duration of the study using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2
Evaluate SMART + AGuIX local control at 12 months compared to SMART alone. Local control at 12 months is defined as the treated tumor is equal to or less than the tumor volume at start of SMART. Progression would be defined per RECIST criteria
Progression-free survival (PFS) at Maximum tolerated dose (MTD)
Assessed by RECIST criteria
Overall Response Rate (ORR) at Maximum tolerated dose (MTD)
Assessed by RECIST criteria
Serious Adverse Events at 90 Days
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
Serious Adverse Events at 12 months
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
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Dana-Farber Cancer Institute
Lead sponsor
TherAguix S.A.
Collaborator
