This is an open-label, phase 1 clinical trial to evaluate the safety and preliminary efficacy of neoadjuvant chemoimmunotherapy (NAI, sotevtamab, and zabadinostat in combination with gemcitabine and nab-paclitaxel) followed by resection and adjuvant immunotherapy for participants with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). Eligible participants will undergo endoscopic ultrasound (EUS)-guided biopsies of the primary pancreatic tumor within 7 days of enrollment and prior to study day 1. EUS-guided biopsies will be used for histopathological examination to give clinical diagnostic information (as SoC) and will be stored in an ethically approved tissue bank.
Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Histologically or cytologically confirmed PDAC that is confined to the pancreas.
Resectable PDAC, meeting the following criteria upon CT/MRI: (a)No superior mesenteric vein (SMV) or portal vein (PV) distortion; (b) Clear fat planes around superior mesenteric artery (SMA), celiac artery (CA), and common hepatic artery (CHA).
Participants for whom an operation is not considered in the participant's best interest (eg, due to comorbidity).
Histologically or cytologically confirmed pancreatic tumor that is not adenocarcinoma.
CA19-9 > 1,000 U/mL.
Single group
Nogapendekin Alfa Inbakicept (N803)
Drug1.2mg SC
Sotevtamab
Drug800mg IV
Zabadinostat (CXD101)
Drug10mg IV
Nab paclitaxel / gemcitabine
DrugNab-Paclitaxel (125mg/m2 IV) and Gemcitabine (1,000 mg/m2 IV)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants experiencing ≥1 treatment-emergent adverse event (TEAE) and ≥1 serious adverse event (SAE), graded per NCI CTCAE v5.0. Adverse events will be coded using MedDRA. Analyses will be performed in the safety population (all participants receiving ≥1 dose of study treatment).
Clinically important changes in laboratory tests and vital signs
Number and percent of participants with protocol-defined clinically important laboratory abnormalities (hematology, chemistry including liver/renal, coagulation) or vital-sign changes that meet action criteria or result in dose modification, treatment interruption, or discontinuation; summarized by grade and action taken.
RFS, defined as time from surgical resection to disease recurrence or death from any cause, whichever occurs first, by RECIST v1.1.
Recurrence-free survival (RFS) measured by RECIST v1.1: time (days) from surgical resection to first documented disease recurrence (radiographic per RECIST v1.1, confirmed per protocol) or death from any cause. Tumor assessments per protocol imaging schedule (every 8 weeks ±1 week) and iRECIST guidance for immune-related events; participants initiating new anticancer therapy or completing follow-up without recurrence are censored at last documented recurrence-free date. Report Kaplan-Meier curve, median RFS and 95% CI, and number (%) of events and censored observations.
R0 resection rate, defined as the percentage of cases having a pathologically complete resection with a negative resection margin.
Percentage of participants with a pathologically confirmed R0 resection (complete resection with negative margins). Report n and %, and exact 95% Clopper-Pearson CI.
ORR by RECIST v1.1
Objective response rate (confirmed CR or PR per RECIST v1.1, confirmation ≥4 weeks after initial response). Report n and %, 2-sided exact 95% CI, and best overall response distribution.
DOR by RECIST v1.1.
Duration of response for participants with confirmed CR/PR by RECIST v1.1. Analyze by Kaplan-Meier; present median DOR and 95% CI, KM curve, and numbers at risk.
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