- Participants must be ≥ 18 years old.
- Participants with SCCHN or mCRCP.
- Participants must have histological diagnosis of solid tumors and provide tumor
tissue.
- Measurable disease by RECIST v1.1 with at least 1 measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Adequate bone marrow, renal and liver function
- Highly effective contraceptive use by men with the ability to father a child or women
of childbearing potential.
- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as
required by local regulations) at C1D1.
- Signed and dated informed consent.
- Known prior severe hypersensitivity to investigational products or any component in
their formulations, including known severe hypersensitivity reactions to monocolonal
antibodies.
- Known history of: immune-mediated colitis, inflammatory bowel disease, pneumonitis, or
pulmonary fibrosis.
- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.
- Prior organ transplantation including allogenic stem cell transplantation.
- Vaccination within 4 weeks prior to C1D1 and while on trial is prohibited except for
administration of inactivated vaccines.
- Known symptomatic brain lesions requiring steroids.
- Known history of testing positive for human immunodeficiency virus (HIV or known
acquired immunodeficiency syndrome (AIDS).
- Positive HBV surface antigen or HCV test indicating acute or chronic infection..
- Active infection requiring systemic therapy
- Clinically significant (i.e., active) cardiovascular disease including the following:
documented left ventricular ejection fraction (LVEF)
vascular accident/stroke; myocardial infarction; unstable angina; congestive heart
failure or serious cardiac arrhythmia (uncontrolled, clinically significant) requiring
medication.
- Diagnosis of any other malignancy within 2 years prior to C1D1, except for adequately
treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast,
bladder or of the cervix and for Combination A only, low-grade (Gleason 6 or below)
prostate cancer on surveillance with no plans for treatment intervention (e.g.,
surgery, radiation, or castration) or adequately treated prostate cancer.
- Current use of immunosuppressive medication at the time of study enrollment.
- Major surgery within 4 weeks prior to study enrollment.
- Conditions that may impair intake or absorption such as inability to swallow capsules
or tablets; known malabsorption syndrome; or baseline diarrhea ? Grade 1.
- Participation in other studies involving investigational drug(s) within 2 weeks prior
to C1D1.