Trial · NCT07893054
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | Objective response rate (dose escalation only) | Up to 60 months | Defined as the proportion of participants in whom a confirmed CR or PR (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response. Per cohort. |
| Secondary | Disease control rate | Up to 60 months | Defined as the proportion of participants in whom confirmed CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response. Per cohort. |
| Secondary | Duration of response | Up to 60 months | Defined as the time from first confirmed objective response (CR or PR based on investigator's assessment per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease based on investigator's assessment per RECIST v1.1) or death from any cause, whichever occurs first. Per cohort. |
| Secondary | Time to response | Up to 60 months | Defined as the time from first dose of study treatment to first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) in participants with a confirmed objective response. Per cohort. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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