NCT07488884

Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer Resectable
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nogapendekin Alfa Inbakicept (N803)	1.2mg SC
DRUG	Sotevtamab	800mg IV
DRUG	Zabadinostat (CXD101)	10mg IV
DRUG	Nab paclitaxel / gemcitabine	Nab-Paclitaxel (125mg/m2 IV) and Gemcitabine (1,000 mg/m2 IV)

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-04-01
• Completion: 2029-06-01
• First posted: 2026-03-23
• Last updated: 2026-03-23

Regulatory

• FDA-regulated drug study