account_circleRecruiting
MTAP-deleted Solid Tumors
Bayer Identifier:
22931
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2025-520623-24-00
A first-in-human study to learn how safe BAY 3713372 is and how it works in participants with MTAP-deleted solid tumors
Trial purpose
The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells.
The main objective of this first-in-human study is to check if BAY 3713372 is safe for further testing and find the dose that could be used to treat different cancer types that are also MTAP-deleted in future studies.
For this, the researchers will study and analyze:
- the number of participants who have adverse events after receiving different doses of BAY 3713372 and their severity.
- the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, their severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.
- the total amount of BAY 3713372 in participants’ blood (also called AUC) over time after single and multiple doses.
- the highest level of BAY 3713372 in participants’ blood (also called Cmax) after single and multiple doses.
Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.
The study participants will receive BAY 3713372 (starting from low to high doses) in the study, to find the highest safe dose for further testing.
Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems.
Participants will visit the study site:
- at least twice before the treatment starts
- multiple times when they start taking the treatment
- once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason
During the study, the doctors and their study team will:
- check participants’ health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram
- check if the participants’ cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan
- take tumor samples
The study doctors and their team will contact the participants every 3 months until 2 years after the last participant’s last dose or the end of the study to learn about the participant’s health.
The main objective of this first-in-human study is to check if BAY 3713372 is safe for further testing and find the dose that could be used to treat different cancer types that are also MTAP-deleted in future studies.
For this, the researchers will study and analyze:
- the number of participants who have adverse events after receiving different doses of BAY 3713372 and their severity.
- the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, their severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.
- the total amount of BAY 3713372 in participants’ blood (also called AUC) over time after single and multiple doses.
- the highest level of BAY 3713372 in participants’ blood (also called Cmax) after single and multiple doses.
Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.
The study participants will receive BAY 3713372 (starting from low to high doses) in the study, to find the highest safe dose for further testing.
Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems.
Participants will visit the study site:
- at least twice before the treatment starts
- multiple times when they start taking the treatment
- once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason
During the study, the doctors and their study team will:
- check participants’ health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram
- check if the participants’ cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan
- take tumor samples
The study doctors and their team will contact the participants every 3 months until 2 years after the last participant’s last dose or the end of the study to learn about the participant’s health.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
70Trial Dates
March 2025 - June 2029Phase
Phase 1Could I Receive a placebo
NoProducts
BAY3713372Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | National Cancer Center Singapore | Singapore, 168583, Singapore |
Not yet recruiting | National University Hospital Medical Centre | Singapore, 119074, Singapore |
Recruiting | START | San Antonio | San Antonio, 78229-3307, United States |
Not yet recruiting | Chris O'Brien Lifehouse | Camperdown, 2050, Australia |
Not yet recruiting | Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre | Concord, 2139, Australia |
Not yet recruiting | SCRI Oncology Partners | Nashville, 37203, United States |
Not yet recruiting | Sarah Cannon Research Institute at HealthONE | Denver, 80218, United States |
Not yet recruiting | Florida Cancer Specialists & Research Institute - Lake Nona | Orlando, 32827, United States |
Not yet recruiting | The Christie NHS Foundation Trust | Christie Hospital - Experimental Cancer Medicine Team | Manchester, M20 5BX, United Kingdom |
Not yet recruiting | The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit | London, SW3 6JJ, United Kingdom |
Not yet recruiting | START | Midwest | Grand Rapids, 49546, United States |
Not yet recruiting | NEXT Dallas | Irving, 75039, United States |
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionarydate_rangeTime Frame:From the first administration of study intervention up to 30 days after the last dose of study intervention
- Number of participants with treatment-emergent serious adverse events (TESAEs)TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionarydate_rangeTime Frame:From the first administration of study intervention up to 30 days after the last dose of study intervention
- Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionarydate_rangeTime Frame:From the first administration of study intervention up to 30 days after the last dose of study intervention
- Incidence of dose-limiting toxicities (DLTs)DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0date_rangeTime Frame:From first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
- Number of participants with DLTsNumber of participants with at least one DLTdate_rangeTime Frame:From first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
- Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372date_rangeTime Frame:From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
- Area under the curve (AUC) of the respective dosing interval of BAY 3713372date_rangeTime Frame:From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Secondary Outcome
- Objective response rate (ORR)Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)date_rangeTime Frame:Approximately 1.5 years
- Duration of response (DOR)Determined by the investigator according to RECIST v1.1date_rangeTime Frame:Approximately 3 years
- Progression-free survival (PFS)Determined by the investigator according to RECIST v1.1date_rangeTime Frame:Approximately 3 years
- Time to response (TTR)date_rangeTime Frame:Approximately 1.5 years
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Sequential AssignmentTrial Arms
1