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Pancreatic Cancer ResectablePhase 1ResQ108B-PANCNCT07488884

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

A Phase 1 study testing Nogapendekin Alfa Inbakicept (N803), Sotevtamab and Zabadinostat (CXD101) in people with Pancreatic Cancer Resectable and Pancreatic Cancer, run by ImmunityBio, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nogapendekin Alfa Inbakicept (N803), Sotevtamab and Zabadinostat (CXD101)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 1 Jun 2029
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Borderline resectable (surgical resection possible but challenging) or locally advanced (surgical resection not possible) PDAC, as determined by the local investigator based onlocal institutional guidelines.
  • Measurable tumor lesions according to RECIST v1.1. (within 90 days prior to first dose of study treatment).
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  • Have not received prior anticancer therapy for pancreatic cancer.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Agreement to practice highly effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up to 7 months after completion of therapy, and nonsterile male participants must agree to use a condom for up to 7 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.

Who cannot join

  • 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.
  • QTc interval using Fridericia's formula (QTcF) > 470 ms.
  • If participants have had major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
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  • Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.
  • Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline: (a) Absolute neutrophil count (ANC) < 1,500 cells/μL without granulocyte colonystimulating factor support, (b) Lymphocyte count < 500/μL, (c) platelet count < 100,000/μL without transfusion (d) Hemoglobin < 8.0 g/dL Note: Participants may be transfused to meet this criterion, (e) International Normalized Ratio (INR) or aPTT activated partial thromboplastin time (aPTT) < 1.5 × upper limit of normal (ULN) Note: This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose. (f) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase > 2.5 × ULN, with the following exception: Participants with documented liver metastases: AST and/or ALT > 5 × ULN. (g) Serum bilirubin ≤ 3 × ULN (h) Creatinine clearance ≤ 60 mL/min (calculated using the Cockcroft-Gault formula), (i) Serum albumin ≤ 3.0 g/dL. (j) Urine dipstick for proteinuria > 2+ (within 7 days prior to initiation of study treatment). Participants with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours.
  • Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina.
  • Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Prior allogeneic bone marrow transplantation or solid organ transplant.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Treatment with systemic immunosuppressive medications (including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to initiation of study treatment, or anticipation of the need for systemic immunosuppressive medication during study treatment, with the following exceptions: (a) A. Participants who have received acute, low-dose, systemic immunosuppressant medications (eg, a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Medical Monitor, (b)B. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (eg, fludrocortisone) for participants with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
  • Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Pregnant and nursing women.

About this study

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.

Being tested
Nogapendekin Alfa Inbakicept (N803), Sotevtamab, Zabadinostat (CXD101), Nab paclitaxel / gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nogapendekin Alfa Inbakicept (N803)Drug

    Also called N-803, ANKTIVA

    1.2mg SC

  • SotevtamabDrug

    800mg IV

  • Zabadinostat (CXD101)Drug

    10mg IV

  • Nab paclitaxel / gemcitabineDrug

    Nab-Paclitaxel (125mg/m2 IV) and Gemcitabine (1,000 mg/m2 IV)

Study groups in NCT07488884
Study groupRoleWhat they receive
Neoadjuvant NAI + sotevtamab + zabadinostat + gemcitabine/nab-paclitaxel; adjuvant NAIExperimentalParticipants 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.
Receives: Drug: Nogapendekin Alfa Inbakicept (N803); Drug: Sotevtamab; Drug: Zabadinostat (CXD101); Drug: Nab paclitaxel / gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 v6.0. Adverse events will be coded using MedDRA.

    Analyses will be performed in the safety population (all participants receiving ≥1 dose of study treatment).

    Measured: 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.

  2. 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.

    Measured: Baseline (pre-dose) through 30 days after last dose (clinically important labs/vitals and related actions); SAE/irAE follow-up 90 days; long-term follow-up through 104 weeks (2 years) post last dose.

Secondary outcomes (12)

  1. 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.

    Measured: From date of surgical resection until documented disease recurrence or death from any cause, whichever occurs first; participants censored at last disease assessment or at 104 weeks (2 years) post last dose.

  2. 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.

    Measured: At time of surgical resection (performed within 8 months of first study dose).

  3. 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.

    Measured: From first study treatment until documented objective response or censoring; tumor assessments every 8 weeks (±1 week) through last treatment dose and per follow-up schedule through 104 weeks.

  4. 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.

    Measured: For responders, from date of first documented CR/PR to date of documented progression or death (any cause); follow until event or censoring through 104 weeks.

  5. Immune Recurrence-Free Survival (iRFS) by iRECIST

    Immune recurrence-free survival (iRFS), defined as time from surgical resection to immune-confirmed recurrence (iCPD per iRECIST) or death from any cause, whichever occurs first. iRFS will be analyzed using Kaplan-Meier methods, with median iRFS and two-sided 95% confidence intervals summarized.

    Measured: From date of surgical resection until immune-confirmed progression (iCPD), death, or censoring, with imaging every 8 weeks (±1 week) through 104 weeks after last dose.

  6. Immune Objective Response Rate (iORR) by iRECIST

    Immune objective response rate (iORR), defined as the proportion of participants with a confirmed immune complete response (iCR) or immune partial response (iPR) per iRECIST. Best overall immune response will be determined, and iORR with two-sided 95% confidence intervals will be summarized.

    Measured: From first dose until immune-confirmed progression (iCPD), death, or censoring, with imaging every 8 weeks (±1 week) through 104 weeks after last dose.

  7. Immune Duration of Response (iDOR) by iRECIST

    Immune duration of response (iDOR), defined for participants with a confirmed iCR or iPR per iRECIST as the time from the first documented iCR/iPR to immune-confirmed progression (iCPD) or death from any cause, whichever occurs first. iDOR will be analyzed using Kaplan-Meier methods, with median iDOR and two-sided 95% confidence intervals summarized.

    Time Frame:

    Measured: From first confirmed iCR or iPR until immune-confirmed progression (iCPD), death, or censoring, with imaging every 8 weeks (±1 week) through 104 weeks after last dose.

  8. OS, defined as time from start of study treatment to death resulting from any cause.

    Overall survival assessed by Kaplan-Meier. Present OS curve, median OS with 95% CI, number (%) of deaths, and survival rates at prespecified timepoints.

    Measured: From date of first study treatment to death from any cause; participants censored at last known alive date; follow through 104 weeks (2 years) post last dose (or longer if protocol specifies).

  9. Major pathologic response, defined as CAP TRG of 0 or 1 at the time of surgical resection.

    Proportion of resected participants with major pathologic response defined as CAP Tumor Regression Grade 0 or 1 on surgical specimen. Report n and %, and exact 95% CI; provide distribution of CAP TRG scores.

    Measured: At time of surgical resection (tissue collected at resection).

  10. Biochemical response, defined as > 50% decrease in CA 19-9 from baseline

    Proportion of participants achieving a biochemical response, defined as >50% decrease in CA 19-9 from baseline. Report n and %, 95% CI, timing to response, and summary statistics (median percent change, time to nadir).

    Measured: From baseline (pre-treatment) through the earliest of disease recurrence/progression, start of new anti-cancer therapy, or 104 weeks after last dose; CA 19-9 measured at baseline and on Day 1 of each 28-day treatment cycle.

  11. Whole Slide Image Availability for Exploratory Image-Outcome Analyses

    Number of participants with evaluable high-resolution whole slide images (H\&E-stained tumor tissue, digital or scanned slides) collected for exploratory analyses. Slides may undergo quantitative histomorphometry, immune/tumor microenvironment characterization, and AI/algorithmic feature extraction. Image-derived features will be analyzed in relation to clinical and pathologic outcomes (e.g., RFS, iRFS, ORR/iORR, DOR/iDOR, OS, CAP TRG) and biomarker data (ctDNA, CA 19-9) using prespecified statistical methods (e.g., multivariable models, supervised/unsupervised learning with adjustment for key covariates). For this Outcome Measure, the primary metric is the number of participants with at least one evaluable whole slide image available for such analyses.

    Measured: From baseline diagnostic biopsy (screening) and/or surgical resection up to End-of-Treatment (EOT), assessed up to 104 weeks after first dose.

  12. Blood for ctDNA analysis.

    Number of participants with evaluable plasma specimens for circulating tumor DNA (ctDNA) analysis. Blood will be collected for tumor-informed and/or tumor-agnostic ctDNA assays to profile somatic alterations and quantify ctDNA levels. For this Outcome Measure, the primary metric is the number of participants with at least one evaluable ctDNA sample at any protocol-specified collection time point.

    Measured: From baseline and Day 1 of neoadjuvant Cycles 3 and 5 (each cycle is 28 days), Day 1 of adjuvant Cycle 1 (28-day cycle), and Day 1 of every third adjuvant cycle thereafter, through End-of-Treatment (EOT), assessed up to 104 weeks after last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Why it stopped: The sponsor has changed the development plans which is not for safety reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488884
Sponsor's protocol ID
ResQ108B-PANC
Acronym
ResQ108B-PANC
Status last verified
Aug 2026
First submitted
20 Nov 2025
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nogapendekin Alfa Inbakicept (N803), Sotevtamab and Zabadinostat (CXD101) in people with Pancreatic Cancer Resectable and Pancreatic Cancer, run by ImmunityBio, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07488884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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