Trial · 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
NCT07488884, Phase 1, Withdrawn, ImmunityBio, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT07488884. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07488884
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT07488884
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- Pancreatic Cancer Resectable, Pancreatic Cancer
- Interventions
- Nogapendekin Alfa Inbakicept (N803), Sotevtamab, Zabadinostat (CXD101), Nab paclitaxel / gemcitabine
- First posted
- 2026-03-23
- Last updated
- 2026-08-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | 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). |
| Primary | Clinically important changes in laboratory tests and vital signs | 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. | 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. |
| Secondary | RFS, defined as time from surgical resection to disease recurrence or death from any cause, whichever occurs first, by RECIST v1.1. | 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. | 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. |
| Secondary | R0 resection rate, defined as the percentage of cases having a pathologically complete resection with a negative resection margin. | At time of surgical resection (performed within 8 months of first study dose). | Percentage of participants with a pathologically confirmed R0 resection (complete resection with negative margins). Report n and %, and exact 95% Clopper-Pearson CI. |
| Secondary | ORR by RECIST v1.1 | 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. | 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. |
| Secondary | DOR by RECIST v1.1. | 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. | 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. |
| Secondary | Immune Recurrence-Free Survival (iRFS) by iRECIST | 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. | 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. |
| Secondary | Immune Objective Response Rate (iORR) by iRECIST | From first dose until immune-confirmed progression (iCPD), death, or censoring, with imaging every 8 weeks (±1 week) through 104 weeks after last dose. | 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. |
| Secondary | Immune Duration of Response (iDOR) by iRECIST | 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. | 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: |
| Secondary | OS, defined as time from start of study treatment to death resulting from any cause. | 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). | Overall survival assessed by Kaplan-Meier. Present OS curve, median OS with 95% CI, number (%) of deaths, and survival rates at prespecified timepoints. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07488884
GET https://conductscience.org/api/trials/v1/NCT07488884/registered