Phase 1b dose of BAY 2416964 in combination with pembrolizumab in advanced solid tumour

• Research type

  Research Study

• Full title

  An open-label, Phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, maximum tolerated or administered dose, pharmacokinetics, pharmacodynamics and efficacy of the Aryl Hydrocarbon Receptor inhibitor (AhRi) BAY 2416964 in combination with pembrolizumab in participants with advanced solid tumors

• IRAS ID

  1003769

• Contact name

  Thomas Wagener

• Contact email

  thomas.wagener@bayer.com

• Sponsor organisation

  Bayer AG

• Eudract number

  2020-003547-28

• Research summary

  A study to learn how safe Aryl Hydrocarbon Receptor inhibitor (AhRi) BAY2416964 is, how it affects the body, the maximum amount that can be given, how it moves into, through, and out of the body, and its action against tumours in adults with advanced solid tumours when taken with pembrolizumab. In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumour cells. The study drug, BAY2416964 blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY2416964 given together with a cancer treatment called pembrolizumab may help shrink tumours. The main aims of this study are:
  -how safe BAY2416964 is
  -how it affects the body
  -the highest dose of BAY2416964 that can be given without too many side effects
  -the action of BAY2416964 against the cancer.
  Participants in this study will get BAY2416964 twice daily in tablet form and pembrolizumab once every 3 weeks as an intravenous infusion (given through a needle into a vein). This study will have two parts. The first part will help find the most appropriate dose that can be given in the second part. Each participant of the first part will be assigned to one specific dose group for BAY2416964. The amount of BAY2416964 that is given increases stepwise from one group to the next. The dose of pembrolizumab will always be the same. Participants of the second part will receive the most appropriate dose of BAY2416964 found in the first part. During the study, participants will receive treatment in 3-week periods called cycles. These cycles will be repeated throughout the trial. Participants will have approximately 4 visits in each cycle. Some of the visits can also be done via phone. During the study, the study doctors will:
  • take blood and urine samples
  • check if the cancer has spread
  • check the overall health
  • ask questions about how participants are feeling and what adverse events they might have

• REC name

  Wales REC 2

• REC reference

  21/WA/0317

• Date of REC Opinion

  2 Nov 2021

• REC opinion

  Further Information Favourable Opinion