Robert C. Martin
The purpose of this study is to test the safety, tolerability, and preliminary effectiveness of the study drug, IP-001, in patients with locally advanced pancreatic cancer that is treated with IRE.
This is a Phase 1b, single-arm trial designed to evaluate the safety and efficacy of administration of intratumoral IP-001 injection following IRE ablation in patients with Stage III, locally advanced pancreatic adenocarcinoma (LAPC).
Inclusion Criteria: * Age ≥ 18 years at time of signing Informed consent Form * Diagnosed with clinical stage III pancreatic cancer (per National Comprehensive Cancer Network \[NCCN\] guidelines) * Has undergone standard of care (per NCCN guidelines) neoadjuvant/induction base chemotherapy for at least 2 months in duration and demonstrated stable or responsive disease, and completed a wash-out period of at least 21 days prior to study treatment * Pancreatic tumor is measurable (bi-dimensional tumor measurements per 3-phase CT scan). If preoperative CT cannot provide 2-dimensional size criteri…
Participants will receive intratumoral injection of 1% IP-001 (diluted to 1 mg/mL, up to 12 mL total) into and around the treated tumor and ablated area immediately following IRE
Participants will undergo IRE of the tumor
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