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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pre-screening:
Signed informed consent for pre-screening
Male or female participants aged ≥ 18 years
Participants with histologically confirmed diagnosis of melanoma, glioblastoma/anaplastic astrocytoma, sarcoma or epithelial ovarian cancer/fallopian tube/primary peritoneal cancer
Availability of archival tumor tissue (5-10 for prescreening, further 20 to be provided at screening)
ECOG ≤2
Main Screening :
Positive SLFN12/PDE3A expression in archival tumour
Minimum life expectancy at least 12 weeks
Documented radiological disease progression after treatment with all available standard of care therapies for advanced/metastatic disease and at least one measurable lesion
Adequate bone marrow, liver, and renal function
Adequate blood clotting
Left ventricular ejection fraction \>50%
All AEs due to previous therapies to CTCAE Grade ≤1. Grade ≤2 neuropathy, fatigue, alopecia, or anorexia, for which further resolution is not expected, may be eligible.
Negative pregnancy test and use of highly effective contraception
Signed informed consent for main screening
You may not be if
Pre-screening:
Any malabsorption conditions
Known HIV infection, active HBV or HCV infection
Known hypersensitivity to PDE3 inhibitors, or excipients in the formulation; concomitant treatment with any other PDE3 inhibitors
Participants with clinically relevant cardiovascular diseases and/or relevant ECG findings
Participants with history of hemorrhage, bleeding disorders or platelet function abnormalities, aneurysm or aneurysmal vasculopathy; Participants with arterial thromboembolic events (ATEs) or venous thromboembolic events (VTEs), including transient ischemic attacks or pulmonary embolism within 6 months before the start of BAY 2666605 or deep vein thrombosis within 3 months before the start of BAY 2666605; Participant with a history of gastrointestinal (GI) ulcerations or perforation, fistula formation involving any internal organs.
Main screening
Moderate or severe hepatic impairment
History of organ allograft transplantation, including allogeneic bone marrow
Previous of co-existing cancer(s) distinct in primary site or histology from the cancer evaluated in this study (with few exceptions)
Participants with any history of primary meningeal tumors and/or Any active symptomatic or untreated central nervous system (CNS) metastases and/or a number of prior and concomitant therapies
Major surgery, significant trauma, serious non-healing wound, wound healing complications, ulcer or bone fracture within 4wks prior to 1st dose
Clareo Health | 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
