Neoadjuvant NAI, Sotevtamab, Zabadinostat + Gemcitabine, Nab-paclitaxel for BR/LAPC
Research type
Research Study
Full title
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
IRAS ID
1013114
Contact name
Charles Garlisi
Contact email
Sponsor organisation
ImmunityBio, Inc.
ISRCTN Number
ISRCTN11357259
Research summary
This study is for people with a type of pancreatic cancer that has not spread far away, but cannot be easily removed with surgery right now.
We want to find out if a new drug combination can make surgery more successful and help control the cancer.
Everyone in the study will receive standard chemotherapy for pancreatic cancer (gemcitabine and nab-paclitaxel). You will also receive three new study medicines that help the immune system attack cancer: nogapendekin alfa inbakicept (NAI), sotevtamab, and zabadinostat. These medicines are still experimental and are not yet approved.
You will get these medicines before surgery. This part is called “neoadjuvant treatment,” which means treatment given before surgery to try to shrink or control the tumour. You may get between 2 and 6 treatment blocks (“cycles”), which usually takes about 2 to 6 months in total. How long you stay on treatment before surgery depends on how your cancer responds and how you are feeling.
If your cancer can then be removed, you will have surgery. After surgery, you may continue on one of the study medicines (NAI) every two weeks. This is sometimes called “maintenance treatment.” You can keep getting it unless the cancer gets worse or the side effects are too strong.
We will check the size of your tumour with scans, and we will take blood and tissue samples to see how the treatment is working in your body.
This is an early-phase (Phase 1) study. That means the main aim is to check safety: what side effects people get and how severe they are. We will also look for early signs that the treatment is helping.
Up to 30 people will take part.
This research may help us understand if this new five-drug combination is safe and could help future patients with pancreatic cancer.REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0389
Date of REC Opinion
9 Jan 2026
REC opinion
Further Information Favourable Opinion