Trial · NCT05614102
A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors
NCT05614102, Phase 1, Active not recruiting, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors. Trials, record NCT05614102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05614102
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors
- NCT number
- NCT05614102
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 284 participants, estimated
- Lead sponsor
- Bayer
- Conditions
- Advanced Solid Tumors
- Interventions
- BAY2965501, Pembrolizumab, Platinum-based Chemotherapy
- First posted
- 2022-11-14
- Last updated
- 2026-07-07
- Other registries' IDs
- eudract:2022-002016-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT05614102
GET https://conductscience.org/api/trials/v1/NCT05614102/registered