Clinical Research Directory

Main Inclusion Criteria: * Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * Male or female aged ≥ 18 years. * Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer (Germany-specific: and have exhausted all standard of care treatments or are not eligible for such treatments) * Progressed on/relapsed after at least one prior anti-PD-1/PD-L1 treatment * Biopsy-accessible tumor lesions and willing to undergo triple sequential tumor biopsy (Part A) and dual biopsy (Part B, only for selected cohorts). * At least 1 radiologically measurable lesion per RECIST V1.1/imRECIST (Part B). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Life expectancy \> 3 months as assessed by the Investigator. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). Main Exclusion Criteria: * Pregnant or breastfeeding. * Any tumor-directed therapy within 21 days before study treatment. * Treatment with investigational agent within 21 days before study treatment. * Radiotherapy within 14 days before study treatment. * Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (NYHA) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time \< 6 months prior to Screening or presence of any uncontrolled heart failure NYHA Grade III or higher. * Left ventricular ejection fraction (LVEF) \< 50% measured by echocardiogram or MUGA. * QTcF \> 450 ms for men or \> 470 ms for women. * Any active autoimmune requiring systemic immunosuppressive treatments. . * Any history of non-infectious pneumonitis \< 6 months prior to Screening. * Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present \< 6 months prior to Screening. * History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (\< 6 months prior to Screening). * Evidence for active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis (TB), or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).