A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced Cancer

Official Title

An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumour Response Profile of the Aryl Hydrocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Participants With Advanced Solid Tumours

Summary:

In this study researchers want to gather relevant information regarding the safety of BAY2416964 and how well the drug works in participants with a type of solid tumours that cannot be cured by currently available drugs. Researchers want to find the highest dose of BAY2416964 that participants could take without having too many side effects, how the drug is tolerated and the way the body absorbs, distributes and gets rid of the study dug. BAY2416964 is a small molecule which blocks the Aryl Hydrocarbon Receptor (a protein involved in immune cell reaction to tumour cells) allowing the body to use its immune response against the tumour cells.

Trial Description

Primary Outcome:

• The incidence of treatment emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) and dose-limiting toxicities (DLTs)
• Severity of treatment emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) and dose-limiting toxicities (DLTs)
• Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964
• Recommended Phase II dose (RP2D) of BAY2416964
• Maximal plasma exposure (Cmax) for once daily (QD) dosing of BAY 2416964 after single-dose and multiple-dose in Cycle 1.
• Area under the curve [AUC (0 - 24)] for QD dosing of BAY 2416964 after single-dose in Cycle 1.
• Alternatively AUC(0-12) for 2 times daily (BID) dosing after single dose in cycle 1 (based on outcome of PK decision point)
• AUC(0-12) after multiple dose

• Objective response rate (ORR) by RECIST 1.1
• Change from baseline in AhR target gene expression in whole blood after ex-vivo stimulation
• Cytokine measurements, e.g. IL-6 (immunoassay), in whole blood after ex-vivo stimulation.

View this trial on ClinicalTrials.gov