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

Sponsor
ImmunityBio, Inc.
Study ID
NCT07488884
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 23, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant NAI + sotevtamab + zabadinostat + gemcitabine/nab-paclitaxel; adjuvant NAI
    Participants receive neoadjuvant therapy of nogapendekin alfa inbakicept (NAI) SC + sotevtamab IV + oral zabadinostat plus gemcitabine and nab-paclitaxel IV for up to 6 × 28-day cycles, with zabadinostat given Days 1-5 (second course Days 15-19 per SRC), sotevtamab/gemcitabine/nab-paclitaxel on Days 1, 8, 15, and NAI on Days 1 and 15 (weight-based ≤50 kg). After ≥2 cycles participants may be reassessed for surgical resection; resected participants receive adjuvant NAI SC on Days 1 and 15 of each 28-day cycle until recurrence, unacceptable toxicity, withdrawal, or investigator decision. Premedication and infusion-reaction management per protocol; safety follow-up per study schedule.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose through 30 days after last dose (SAEs and immune-related AEs followed for 90 days after last dose); survival/safety follow-up through 104 weeks (2 years) post last dose. ]

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