Study type: Immunotherapy Study type: Targeted therapy
Found:
10 trials shown from 532 total

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

25 October 2021

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer. This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations. The main aims of this study are to find for BAY2927088 how safe BAY2927088 is how it affects the body (also referred to as tolerability) how BAY2927088 moves into, through and out of the body the maximum amount of BAY2927088 that the participants can take without too many side effects. The researchers will also study the action of BAY2927088 against the cancer. This study will have three parts. The first part will help find the most appropriate dose that can be given in the third part. Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next. The participants of the second, so called Backfill part will be assigned any specific dose that has already been tested during Part 1 and found to be safe. The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. During the study, the participants will take the study treatment in 3 week periods called "cycles". They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle. During the study, the study team will: take blood and urine samples take regular CT or MRI scans to check if the participants' cancer has gotten better or worse check the participants' overall health and heart health ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Trial number:
NCT05099172
Trial phase:
1
Overall status:
Recruiting
Study type:
Targeted therapy

A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults

30 August 2021

Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer. In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer. The main aims of this study are to find for BAY 2416964 in combination with pembrolizumab, how safe this drug combination is how it affects the body (also referred to as tolerability) the highest amount of BAY 2416964 that can be given in combination with pembrolizumab without too many side effects. The researchers will also study the action of BAY 2416964 in combination with pembrolizumab against the cancer. The participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will be given in tablet form by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV infusion is 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, so called dose escalation part, will be assigned to one specific dose group for BAY 2416964. The amount of BAY 2416964 that is given increases step-wise from one group to the next. The dose of pembrolizumab will always be the same. The participants of the second, so called dose expansion part, will receive the most appropriate dose of BAY 2416964 found in the first part. During the study, the participants will receive the treatment in 3-week periods called cycles. In each cycle, the participants will in general get pembrolizumab once and BAY 2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial. The participants can take the study treatment until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 4 visits in each cycle. Some of the visits can also be done via phone. During the study, the study doctors and their team will: take blood and urine samples check if the participants' cancer has spread using computed tomography scans or magnetic resonance imaging scans of the participants' tumors check the participants' overall health ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Trial number:
NCT04999202
Trial phase:
1
Overall status:
Recruiting
Study type:
Immunotherapy