Trial · NCT07886684
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A only: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period | Up to 21 days from the initiation of first dose of study treatment | Defined as the first 21 days. By dose level. |
| Primary | Occurrence of treatment emergent adverse events (TEAEs) by grade, seriousness, and relatedness | Up to approximately 3 years from first dose of study treatment | From first dose of BNT3210 until 35 days after the last dose of BNT3210 or the start of new anti-cancer treatment, whichever is earlier. |
| Primary | Occurrence of dose interruptions, reductions, and discontinuation of BNT3210 due to TEAEs | Up to approximately 3 years from first dose of study treatment | From the time of initiation of the first dose of BNT3210 until administration of the last dose of BNT3210 or the start of new anti-cancer treatment, whichever is earlier. |
| Primary | Part B only: Objective response rate (ORR) | Up to approximately 3 years from first dose of study treatment | Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (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. |
| Secondary | PK assessment: Area under the curve (AUC) derived from serum concentrations of BNT3210 | Up to approximately 42 days after last dose of study treatment | By dose level at treatment cycle. If data permits. |
| Secondary | PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3210 | Up to approximately 42 days after last dose of study treatment | By dose level at treatment cycle. If data permits. |
| Secondary | PK assessment: Time to Cmax (Tmax) derived from serum concentrations of BNT3210 | Up to approximately 42 days after last dose of study treatment | By dose level at treatment cycle. If data permits. |
| Secondary | PK assessment: Elimination half-life (t1/2) derived from serum concentrations of BNT3210 | Up to approximately 42 days after last dose of study treatment | By dose level at treatment cycle. If data permits. |
| Secondary | Part A only: ORR | Up to approximately 3 years from first dose of study treatment | Defined as the proportion of participants in whom a confirmed CR or PR (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response. |
| Secondary | Disease control rate | Up to approximately 3 years from first dose of study treatment | Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST v1.1 based on investigator's assessment) is observed as best overall response. |
| Secondary | Duration of response | Up to approximately 3 years from first dose of study treatment | Defined as the time from first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first. |
| Secondary | Anti-drug antibody (ADA) prevalence | Up to approximately 42 days after last dose of study treatment | ADA prevalence is defined as the percentage of participants who are ADA positive at any point in time (either baseline or post-baseline). |
| Secondary | ADA incidence | Up to approximately 42 days after last dose of study treatment | ADA incidence is defined as the proportion of participants having treatment-emergent ADA during the study period. |
| Secondary | Part B only: Progression free survival | Up to approximately 3 years from first dose of study treatment | Defined as the time from first dose of BNT3210 to first objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first. |
| Secondary | Part B only: Overall survival | Up to approximately 3 years from first dose of study treatment | Defined as the time from first dose of BNT3210 to death from any cause. |
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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GET https://conductscience.org/api/trials/v1/NCT07886684/registered