Trial · NCT05614102
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The frequency and severity of treatment-emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) | Up to 90 days after the last administration of study treatment | |
| Primary | Maximum Tolerated Dose (MTD): Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the study | From first dose of study treatment to the end of Cycle 1 (each cycle is 21 days) | |
| Primary | Maximum Administered Dose (MAD): Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the study | From first dose of study treatment to the end of Cycle 1 (each cycle is 21 days) | |
| Primary | Maximum concentration (Cmax) of the respective dosing interval of BAY2965501 after single dose and multiple-dose | From pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days) | |
| Primary | Area under the curve [AUC (0 - 24)] of the respective dosing interval of BAY 2965501 after single-dose and multiple-dose | From pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days) | If AUC(0-24) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC(0-tlast) as primary variable. |
| Secondary | Objective response rate (ORR) | Approximately 6 months | Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1) |
| Secondary | Disease control rate (DCR) | Approximately 6 months | Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1) |
| Secondary | Duration of response (DOR) | Approximately 6 months | Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1) |
| Secondary | Progression-free survival (PFS) rate at 6 months | At 6 months | Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1) |
| Secondary | Overall survival (OS) rate at 12 months | At 12 months | |
| Secondary | Change from baseline in peripheral activation of effector T memory cells as assessed by flow cytometry | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | |
| Secondary | Change from baseline in interleukin 2 and interferon-gamma levels after ex-vivo stimulation | Screening, Cycle 1: Day 1, Day 8 (each cycle is 21 days) |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05614102/registered