stop_circleTerminated/Withdrawn
Metastatic melanoma and other solid tumors
Bayer Identifier:
20733
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to learn how safe BAY2666605 is, how it affects the body, how it moves into, through and out of the body, the maximum amount that can be given and its action against tumors in adult participants with skin cancer that has spread to other parts of the body and other types of advanced cancer
Trial purpose
Researchers are looking for a better way to treat people who have advanced cancer.
In this study researchers want to learn more about a new substance called BAY2666605. BAY2666605 triggers the formation of a complex of two proteins called SLFN12 and PDE3A. This complex drive cancer cells into cell death by a mechanism called apoptosis. The complex is only formed in the cancers which contain both proteins.
This study is done in adult patients who have certain types of advanced cancers that cannot be cured by drugs that are currently available. The cancer types include skin cancer that has spread to other parts of the body and cancer that started in the bones or soft tissue, the ovaries, or the brain. Patients with these cancers are only included if the cells of the patient’s cancer contain the building plan to produce SLFN12-phosphodiesterase 3A (PDE3A) complex. To confirm this, a specific test is performed with the cancer cells.
The researchers will study how BAY2666605 moves into, through and out of the body. Researchers will try to find the best dose that can be given, how safe BAY2666605 is and how it affects the body. Researchers will also study the action of BAY2666605 against the cancer. Part A will include about 36 participants and up to another 12 participants. Part B will include about 41 participants. All of the participants will take BAY2666605 by mouth as either a liquid or as tablets.
During the study, the participants will take the treatment in 4 week periods called cycles. In each cycle, the participants will in general take BAY2666605 once daily. The participants may also be asked to do overnight fasting before the intake of substance and to have standard high-fat, high-calorie breakfast on some days before taking the dose.
These 4 week cycles will be repeated throughout the trial. The participants can take BAY2666605 until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 18 visits in each cycle. Some of the visits can also be done via Phone.
During the trial, the study team will take blood and urine samples, do physical examinations and check the participants’ heart health using an electrocardiogram (ECG) and an ultrasound of the heart. The study team will also take pictures of the participants’ tumors using CT or MRI scans. The study team will ask how the participants are feeling, if participants have any medical problems or if participants are taking any other medicine. About 1 month and 3 months after the last dose, the participants will have another visit and a phone call respectively where participants will be checked for and asked about medical problems. The researchers will then contact the participants every 3 months until the trial ends.
In this study researchers want to learn more about a new substance called BAY2666605. BAY2666605 triggers the formation of a complex of two proteins called SLFN12 and PDE3A. This complex drive cancer cells into cell death by a mechanism called apoptosis. The complex is only formed in the cancers which contain both proteins.
This study is done in adult patients who have certain types of advanced cancers that cannot be cured by drugs that are currently available. The cancer types include skin cancer that has spread to other parts of the body and cancer that started in the bones or soft tissue, the ovaries, or the brain. Patients with these cancers are only included if the cells of the patient’s cancer contain the building plan to produce SLFN12-phosphodiesterase 3A (PDE3A) complex. To confirm this, a specific test is performed with the cancer cells.
The researchers will study how BAY2666605 moves into, through and out of the body. Researchers will try to find the best dose that can be given, how safe BAY2666605 is and how it affects the body. Researchers will also study the action of BAY2666605 against the cancer. Part A will include about 36 participants and up to another 12 participants. Part B will include about 41 participants. All of the participants will take BAY2666605 by mouth as either a liquid or as tablets.
During the study, the participants will take the treatment in 4 week periods called cycles. In each cycle, the participants will in general take BAY2666605 once daily. The participants may also be asked to do overnight fasting before the intake of substance and to have standard high-fat, high-calorie breakfast on some days before taking the dose.
These 4 week cycles will be repeated throughout the trial. The participants can take BAY2666605 until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 18 visits in each cycle. Some of the visits can also be done via Phone.
During the trial, the study team will take blood and urine samples, do physical examinations and check the participants’ heart health using an electrocardiogram (ECG) and an ultrasound of the heart. The study team will also take pictures of the participants’ tumors using CT or MRI scans. The study team will ask how the participants are feeling, if participants have any medical problems or if participants are taking any other medicine. About 1 month and 3 months after the last dose, the participants will have another visit and a phone call respectively where participants will be checked for and asked about medical problems. The researchers will then contact the participants every 3 months until the trial ends.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
5Trial Dates
April 2021 - April 2023Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2666605Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Withdrawn | Mayo Clinic - Rochester | Rochester, 55905, United States |
Withdrawn | Yale University School of Medicine | New Haven, 06510, United States |
Completed | South Texas Accelerated Research Therapeutics | START San Antonio | San Antonio, 78229-3307, United States |
Withdrawn | Dana-Farber Cancer Institute | Boston, 02215-5450, United States |
Withdrawn | Massachusetts General Hospital | Boston, 02114, United States |
Completed | Sarah Cannon Development Innovations | Nashville, 37203, United States |
Withdrawn | Beth Israel Deaconess Medical Center | Boston, 02215, United States |
Withdrawn | UPMC Hillman Cancer Center | Pittsburgh, 15232, United States |
Primary Outcome
- Incidence and severity of TEAEs including TESAEsTEAEs: Treatment emergent adverse events; TESAEs:Treatment emergent serious adverse eventsdate_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
- The incidence of DLTs at each dose level in the Dose Escalation part of the studyDLT: Dose limiting toxicitydate_rangeTime Frame:Up to 28 + 14 days
- Maximal plasma exposure (Cmax) of BAY2666605date_rangeTime Frame:Cycle 1 Day 1
- AUC(0-24) of BAY2666605date_rangeTime Frame:Cycle 1, Day 1
- RP2D of BAY2666605RP2D: Recommended phase 2 dose. RP2D will be defined in the expansion part.date_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
- Cmax,md of BAY2666605date_rangeTime Frame:Cycle 1, Day 15
- AUC(0-24)md of BAY2666605date_rangeTime Frame:Cycle 1, Day 15
Secondary Outcome
- ORRORR: Objective response ratedate_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
- DCRDCR: Disease control ratedate_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
- DORDOR: Duration of responsedate_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
- PFS by investigator assessmentPFS: Progression-free survivaldate_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
- OSOS: Overall survivaldate_rangeTime Frame:Up to 6 months after the last participant’s first study intervention or until the end of the study, whichever comes first.
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2