A First-in-human Study of ILDR2 (Immunoglobulin-like Domain Containing Receptor 2) Function-blocking Antibody BAY1905254

Inclusion Criteria:

- Male or female patients aged ≥ 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

- Patients with following histologically confirmed, advanced solid tumors are eligible:

- Dose escalation: all solid tumor types with a likelihood of sensitivity to
immunotherapy, as judged by the investigator.

- Tumor type-specific high-dose (at MTD or MAD(Maximum administered dose))
expansion cohorts: urothelial cancer, HNSCC and cervical cancer.

--- TMB (Tumor mutational burden) enrichment phase only: each tumor type-specific
expansion cohort will be enriched with at least 6 patients with medium-to-high
TMB (≥ 10 mutations/Mb).

- Tumor type-specific low-dose expansion cohort (optional): any tumor type based on
data from dose escalation and expansion indicating pharmacodynamics effect.

- Provision of archival tumor tissue at screening is mandatory.

- Patients must have received standard therapy or have no standard therapy available or
patients have actively refused any treatment which would be regarded standard. Or, in
the opinion of investigator have been considered ineligible for a particular form of
standard therapy on medical grounds.

- Adequate bone marrow, liver and renal function.

- Adequate cardiac function, measured by echocardiography.

- All dose expansion cohorts: willingness to undergo paired biopsy of tumor.

Exclusion Criteria:

- History of severe immune related adverse effects from prior immunotherapy (CTCAE v.5.0
Grade 4; CTCAE v.5.0 Grade 3 requiring treatment > 4 weeks), except hypothyroidism
clinically stable on hormone replacement treatment and controlled type 1 diabetes.

- Severe (CTCAE v.5.0 Grade ≥ 3) infections within 4 weeks before the first study drug
administration, including but not limited to hospitalization for complications of
infection, bacteremia, or severe pneumonia. Clinically active infections (CTCAE v.5.0
> Grade 1) within 2 weeks before the first study drug administration.

- Previous or active myocarditis/myositis in history (independent of cause)

- Active or history of autoimmune disease.

- Known human immunodeficiency virus (HIV) infection.

- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

- Treatment with systemic immunosuppressant medications within 2 weeks before the first
study drug administration.

- Ongoing or previous anti-cancer treatment or any immunostimulatory treatment including
but not limited to interferons (IFNs), interleukin (IL)-2 and agonists for members of
the tumor necrosis factor (TNF) receptor superfamily (e.g. 4-1BB) within 4 weeks
before the first study drug administration. Prior treatment with other
immune-checkpoint inhibitors is acceptable if patients are in disease progression
according to response evaluation criteria in solid tumors (RECIST) 1.1.