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Clinical trial to evaluate the safety, tolerability, maximum tolerated or administered dose, pharmacokinetics, pharmacodynamics and tumor response of the diacylglycerol kinase zeta inhibitor (DGKzi) BAY 2965501 in monotherapy and in combination,
THE GOAL OF THIS TRIAL IS TO 1) LEARN WHETHER THE NEW DRUG, BAY 2965501, GIVEN ALONE OR IN COMBINATION WITH PEMBROLIZUMAB, IS SAFE FOR PARTICIPANTS AND HOW IT AFFECTS THE BODY; 2) TRY TO FIND THE BEST DOSE OF THE NEW DRUG TO GIVE TO PARTICIPANTS; 3) LEARN HOW THE DRUG IN THIS TRIAL IS TAKEN UP, MOVES AROUND INSIDE, AND IS ELIMINATED FROM THE BODY. THIS IS KNOWN AS "PHARMACOKINETICS".
Technical Summary
- PHASE 1, FIRST-IN-HUMAN, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, MAXIMUM TOLERATED OR ADMINISTERED DOSE, PHARMACOKINETICS, PHARMACODYNAMICS, AND TUMOR RESPONSE OF THE DIACYLGLYCEROL KINASE ZETA INHIBITOR (DGKZI) BAY 2965501 IN MONOTHERAPY AND IN COMBINATION IN PATIENTS WITH ADVANCED SOLID TUMORS.
- Code EudraCT: 2022-002016-23
- Protocol number: BAY 2965501 / 21948
- Promoter: Bayer HealthCare AG
- Molecule/Drug: BAY 2965501
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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