account_circleRecruiting
Advanced solid tumors
Bayer Identifier:infoA unique number for a trial given by Bayer.
21948
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
2023-507905-33-00
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
Trial purpose
Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are types of cancer that may have spread to nearby tissue, lymph nodes, and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments. This study focuses on certain types of skin cancer, kidney cancer, stomach cancer, and lung cancer. The study treatment BAY2965501 is currently under development as monotherapy or in combination for the treatment of people with advanced solid tumors. BAY2965501 blocks an enzyme in T-cells to activate them. T-cells are a type of immune cell that are known to have an anti-cancer effect and BAY2965501 is a potential new immunotherapy. The main purpose of this first-in-human study is to learn: • how safe different doses of BAY2965501 are when given as a single drug or in combination, • the degree to which medical problems caused by BAY2965501 when given as a single drug or in combination, can be tolerated (also called tolerability), • what maximum amount can be given as a single drug or in combination, and • how it moves into, through and out of the body as a single drug or in combination. To answer this, researchers will look at: • the number and severity of medical problems participants have after taking BAY2965501 as a single drug or in combination for each dose level. These medical problems are also referred to as adverse events. • the (average) total level of BAY2965501 in the blood (also called AUC) after intake of single and multiple doses • the (average) highest level of BAY2965501 in the blood (also called Cmax) after intake of single and multiple doses Doctors keep track of all medical problems that participants have during the study, even if they do not think the medical problem might be related to the study treatment. In addition, the researchers want to know if and how the participants’ tumors change after taking BAY2965501. The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose that can be given in the second part. For this, participants will be assigned to receive one of the planned doses and schedules of BAY2965501 as single drug or participants will be assigned to one of the increasing doses of BAY2965501 in combination with 200mg pembrolizumab. Additionally, platinum based chemotherapy as decided by the treating investigator will be given within the first months (at minimum 2 cycles and up to 6 cycles maximum). Here participants will receive BAY 2965501 in combination with pembrolizumab and platinum based chemotherapy.
All participants will take BAY2965501 by mouth. Additionally, in combination group 1, pembrozilumab will be given as infusion using a small tube that goes into your vein. In combination group 2, pembrolizumab and platinum based chemotherapy will be given as infusion using a small tube that goes into your vein.
In the second part, called dose expansion, all participants in the single drug group will receive up to 2 of the most appropriate doses of BAY2965501 from the 1st part as tablet by mouth. The participants in the combination groups (group 1: + pembrozilumab; group 2: + pembrolizumab and platinum based chemotherapy) will receive the most appropriate dose of BAY2965501 from the first part. Participants in both parts of the study, will take the study treatment until the tumor gets worse (also known as ‘disease progression’), or until the participants have medical problems. In general, the study treatment is planned for a maximum of 35 cycles. Each participant will be in the study for several months, including a screening phase of up to 28 days, few months of treatment depending on the participant’s benefit, and a follow up phase after the end of treatment. Participants in part two will be assigned to one of 3 groups depending on cancer characteristics.During the study, the study team will: • take blood and urine samples • do physical examinations • check vital signs such as blood pressure, heart rate, body temperature • examine heart health using ECG (electrocardiogram) • check if the participants’ cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan • take tumor samples (if required) The treatment period ends with a visit no later than 7 days after the last BAY2965501 dose in the single drug and combination group. About 30 and 90 days after the last dose and every 12 weeks thereafter, the study team will check the participants’ health and any changes in cancer. This follow-up period ends with worsening of the cancer, start of new anti-cancer therapy, or until the participant leaves the study.
All participants will take BAY2965501 by mouth. Additionally, in combination group 1, pembrozilumab will be given as infusion using a small tube that goes into your vein. In combination group 2, pembrolizumab and platinum based chemotherapy will be given as infusion using a small tube that goes into your vein.
In the second part, called dose expansion, all participants in the single drug group will receive up to 2 of the most appropriate doses of BAY2965501 from the 1st part as tablet by mouth. The participants in the combination groups (group 1: + pembrozilumab; group 2: + pembrolizumab and platinum based chemotherapy) will receive the most appropriate dose of BAY2965501 from the first part. Participants in both parts of the study, will take the study treatment until the tumor gets worse (also known as ‘disease progression’), or until the participants have medical problems. In general, the study treatment is planned for a maximum of 35 cycles. Each participant will be in the study for several months, including a screening phase of up to 28 days, few months of treatment depending on the participant’s benefit, and a follow up phase after the end of treatment. Participants in part two will be assigned to one of 3 groups depending on cancer characteristics.During the study, the study team will: • take blood and urine samples • do physical examinations • check vital signs such as blood pressure, heart rate, body temperature • examine heart health using ECG (electrocardiogram) • check if the participants’ cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan • take tumor samples (if required) The treatment period ends with a visit no later than 7 days after the last BAY2965501 dose in the single drug and combination group. About 30 and 90 days after the last dose and every 12 weeks thereafter, the study team will check the participants’ health and any changes in cancer. This follow-up period ends with worsening of the cancer, start of new anti-cancer therapy, or until the participant leaves the study.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal info
284The overall number of participants needed for a trial.
Trial Dates info
November 2022 - June 2027Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
BAY2965501A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
Status | Institution | Location |
---|---|---|
Recruiting | START | San Antonio | San Antonio, 78229, United States |
Recruiting | Sarah Cannon Research Institute at HealthONE | Denver, 80218, United States |
Recruiting | Oxford University Hospitals NHS Foundation Trust | Churchill Hospital - Oncology | Oxford, OX3 7LE, United Kingdom |
Recruiting | Freeman Hospital | Newcastle, NE7 7DN, United Kingdom |
Recruiting | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | National Cancer Center Hospital East | Kashiwa, 277-8577, Japan |
Recruiting | Hospital Universitari Vall d'Hebron - Institut d'Oncologia - Grupo de Tumores Toracicos y Cancer de Cabeza y Cuello | Barcelona, 08035, Spain |
Recruiting | The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro Location | Madrid, 28050, Spain |
Recruiting | Universidad de Navarra - Centro de Investigacion Medica Aplicada (CIMA) | Pamplona, 31008, Spain |
Recruiting | START | Barcelona | Barcelona, 08023, Spain |
Recruiting | Ghent University Hospital | Drug Research Unit Department | Gent, 9000, Belgium |
Recruiting | Antwerp University Hospital | Oncology Department | Antwerpen, 2650, Belgium |
Recruiting | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Recruiting | Samsung Medical Center | Seoul, 135-710, Korea,_republic_of |
Recruiting | Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea,_republic_of |
Recruiting | Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid | Madrid, 28027, Spain |
Recruiting | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing, 100000, China |
Recruiting | UPMC Hillman Cancer Center | Pittsburgh, 15232, United States |
Recruiting | Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | London, SE1 9RT, United Kingdom |
Recruiting | Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Shenzhen, 518172, China |
Recruiting | Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine | Hangzhou, 310016, China |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- The frequency and severity of treatment-emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs)date_rangeTime Frame:Up to 90 days after the last administration of study treatment
- Maximum Tolerated Dose (MTD): Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the studydate_rangeTime Frame:From first dose of study treatment to the end of Cycle 1 (each cycle is 21 days)
- Maximum Administered Dose (MAD): Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the dose escalation part of the studydate_rangeTime Frame:From first dose of study treatment to the end of Cycle 1 (each cycle is 21 days)
- Maximum concentration (Cmax) of the respective dosing interval of BAY2965501 after single dose and multiple-dosedate_rangeTime Frame:From pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
- Area under the curve [AUC (0 – 24)] of the respective dosing interval of BAY 2965501 after single-dose and multiple-doseIf AUC(0-24) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC(0-tlast) as primary variable.date_rangeTime Frame:From pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Objective response rate (ORR)Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1)date_rangeTime Frame:Approximately 6 months
- Disease control rate (DCR)Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1)date_rangeTime Frame:Approximately 6 months
- Duration of response (DOR)Investigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1)date_rangeTime Frame:Approximately 6 months
- Progression-free survival (PFS) rate at 6 monthsInvestigator assessment using Response Evaluation Criteria in Solid Tumours version (RECIST 1.1)date_rangeTime Frame:At 6 months
- Overall survival (OS) rate at 12 monthsdate_rangeTime Frame:At 12 months
- Change from baseline in peripheral activation of effector T memory cells as assessed by flow cytometrydate_rangeTime Frame:From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
- Change from baseline in interleukin 2 and interferon-gamma levels after ex-vivo stimulationdate_rangeTime Frame:Screening, Cycle 1: Day 1, Day 8 (each cycle is 21 days)
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Sequential AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
6A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.