Advanced Pancreatic Cancer Clinical Trial
Official title:
Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.
The purpose of this study is to evaluate the safety and tolerability of escalating doses, to
identify the Maximum Tolerated Dose (MTD) and designate a dose level for Phase II study
(RP2D) of ALT-803 administered in combination with gemcitabine and nab-paclitaxel in patients
with advanced pancreatic cancer.
To access the anti-tumor activity of ALT-803 administered in combination with gemcitabine and
nab-paclitaxel as measured by objective response rate, overall survival, progression-free
survival, time to progression, and duration of response in patients with advanced pancreatic
cancer.
To Characterize the pharmacokinetic, immunogenicity, and serum cytokine profile of ALT-803 in
combination with gemcitabine and nab-paclitaxel in treated patients. To correlate circulating
cell free DNA and circulating tumor DNA with clinical outcomes of the study in treated
patients.
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