ProDa BioTech, LLC
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine, nab-paclitaxel (G-nP) or gemcitabine, nab-paclitaxel (G-nP) and atezolizumab in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC)
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine, nab-paclitaxel (G-nP) or gemcitabine, nab-paclitaxel (G-nP) and atezolizumab in previously untreated subjects with metastatic PDAC. The study will use an EWOC design in Phase I to determine the recommended RP2D of ProAgio with gemcitabine, nab paclitaxel (G-nP) and atezolizumab. After the estimation of RP2D of ProAgio alone, the trial will continue to estimate the RP2D of ProAgio when combined with G-nP, starting from 2 dose…
Inclusion Criteria: 1. Must be ≥ 18 years of age on day of signing informed consent. 2. Histologic or cytologic diagnosis of pancreatic adenocarcinoma with clinical stage IV. 3. In the dose escalation phase: patients must be eligible for gemcitabine and nab paclitaxel. For dose expansion phase: patients must have received 5FU-based therapy for metastatic disease or for neoadjuvant/adjuvant therapy in prior 12 months. 4. Presence of a lesion that can be safely biopsied for correlative assays. 5. Patient must meet the following laboratory values at the screening visit: * Absolute Neutrophil…
ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
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