Trial · NCT07255404
A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer
NCT07255404, Phase 2, Recruiting, BioNTech SE
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer. Trials, record NCT07255404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07255404
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer
- NCT number
- NCT07255404
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 105 participants, estimated
- Lead sponsor
- BioNTech SE
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Interventions
- Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX
- First posted
- 2025-12-01
- Last updated
- 2026-07-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed overall response rate | Up to 24 months | For each treatment arm. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response. |
| Primary | Occurrence of treatment emergent adverse events (TEAEs) by severity | From the first dose of study treatment until 90 days after the last dose of study treatment (up to 32 months). | According to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship and for each treatment arm. |
| Primary | Occurrence of dose interruptions, reductions, and discontinuations due to TEAEs | Up to 24 months after first dose | For each treatment arm. |
| Secondary | Disease control rate | Up to 24 months | Defined as the percentage of study participants in whom a confirmed CR or confirmed PR or stable disease (SD), (per RECIST v1.1, SD assessed at least 6 weeks after randomization/assignment to treatment) is observed as best overall response. |
| Secondary | Duration of response | Up to 30 months | Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (disease progression as assessed by the investigator per RECIST v1.1), or death from any cause, whichever occurs first. |
| Secondary | Progression free survival | Up to 32 months | Defined as the time from first dose of study treatment to first documented tumor progression (disease progression assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first. |
| Secondary | Overall survival | Up to 32 months | Defined as the time from first dose of study treatment to death from any cause. |
| Secondary | Pharmacokinetic (PK) assessment: Maximum concentration (Cmax) derived from serum concentration of pumitamig | Up to 6 months from first dose of study treatment | At Cycle 1 and Cycle 6 as data permits. |
| Secondary | PK assessment: Minimum concentration (Cmin) derived from serum concentration of pumitamig | Up to 6 months from first dose of study treatment | At Cycle 1 and Cycle 6 as data permits. |
| Secondary | Incidence of detectable pumitamig anti-drug antibodies in serum | Up to 32 months | From before the first dose of study treatment until the last survival follow-up visit. |
Source ClinicalTrials.gov
Outcomes0
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT07255404
GET https://conductscience.org/api/trials/v1/NCT07255404/registered