Trial · NCT07893054
A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs
NCT07893054, Phase 1, Not yet recruiting, BioNTech SE
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs. Trials, record NCT07893054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893054
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs
- NCT number
- NCT07893054
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 207 participants, estimated
- Lead sponsor
- BioNTech SE
- Conditions
- Advanced Solid Tumors
- Interventions
- BNT3219
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of dose-limiting toxicities (dose escalation only) | Up to 21 days from the initiation of first dose of investigational medicinal product (IMP) | During the dose-limiting toxicity evaluation period. Per cohort. |
| Primary | Number and percentage of participants with treatment emergent adverse events (TEAEs) by TEAEs by National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness | From the time of dosing until 90 days after the last dose of IMP | Per cohort. |
| Primary | Number and percentage of participants with dose interruptions, or discontinuations of study treatment due to TEAEs | From the first until the last dose of study treatment (up to approximately 30 months) | Per cohort. |
| Primary | Objective response rate (dose expansion only) | Up to 60 months | Defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) (per the Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) as best overall response. |
| Secondary | Pharmacokinetic (PK) assessment: Area under the curve (AUC) derived from serum concentrations of BNT3219 | Up to approximately 90 days after the last dose of IMP | After single- and multiple-dosing. Per cohort. As data permits. |
| Secondary | PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3219 | Up to approximately 90 days after the last dose of IMP | After single- and multiple-dosing. Per cohort. As data permits. |
| Secondary | PK assessment: Time to reach maximum (peak) serum concentration (Tmax) derived from serum concentrations of BNT3219 | Up to approximately 90 days after the last dose of IMP | After single- and multiple-dosing. Per cohort. As data permits. |
| Secondary | PK assessment: Elimination half-life (t1/2) derived from serum concentrations of BNT3219 | Up to approximately 90 days after the last dose of IMP | After single- and multiple-dosing. Per cohort. As data permits. |
| Secondary | Anti-drug antibody (ADA) prevalence | Up to 90 days from the last dose of IMP | Defined as the proportion of participants who are ADA positive (either baseline or post baseline). Per cohort. As data permits. |
| Secondary | ADA incidence | Up to 90 days from the last dose of IMP | Defined as the proportion of participants having treatment-emergent ADA. Per cohort. As data permits. |
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.
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/NCT07893054
GET https://conductscience.org/api/trials/v1/NCT07893054/registered