Inclusion Criteria:
1. Signed and dated the written informed consent form (ICF) prior to any trial-specific
procedures
2. Male or female aged ≥ 20 years (no upper limit of age) at the time of ICF signature
3. Japanese ethnicity, according to the following criteria:
-- born in Japan, have lived outside of Japan <10 years, and have parents and
grandparents who are Japanese
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the
screening visit
5. Life expectancy of at least 3 months
6. Patients with at least one Signal Regulatory Protein-alpha (SIRPα) V1 allele will be
selected, i.e. homozygous V1/V1 or heterozygous V1/V2; SIRPα polymorphism will be
assessed in blood sampling (patient DNA); V1 allele is understood to include V1 and
V1-like alleles
7. Patients with histologically or cytologically documented advanced/metastatic primary
or recurrent solid tumors who failed or are not eligible to standard therapy
8. Patients with at least one measurable lesion as per RECIST v1.1 Further inclusion
criteria apply.
Exclusion Criteria:
1. Patients without at least one SIRPα V1 allele, i.e. SIRPα V2/V2 individuals
2. Previous treatment with study medications in this trial
3. Patients with symptomatic/active central nervous system (CNS) metastases. Patients
with previously treated brain metastases are eligible, if there is no evidence of
progression for at least 28 days before the first study drug administration without
requirement for treatment with corticosteroids, as ascertained by clinical examination
and brain imaging magnetic resonance imaging (MRI) or computed tomography (CT)) during
the screening period
4. Any tumor location necessitating an urgent therapeutic intervention (e.g., palliative
care, surgery or radiation therapy, such as spinal cord compression, other compressive
mass, uncontrolled painful lesion, bone fracture)
5. Presence of active invasive cancers other than the one treated in this trial within 5
years prior to screening, except appropriately treated basal cell carcinoma of the
skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured
by local treatment
6. Patients with active autoimmune disease or a documented history of autoimmune disease,
that requires systemic treatment, i.e. corticosteroids or immunosuppressive drugs,
except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any
chronic skin condition that does not require systemic therapy, patients with
autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
7. Patients who has experienced severe infusion related reaction (IRR) to monoclonal
antibody (mAb) (Grade ≥ 3 NCI CTCAE v5.0)
8. Patients removed from previous anti-PD-1 or anti-PD-L1 therapy because of a severe, or
life-threatening immune related adverse event (irAE) (Grade ≥ 3 NCI CTCAE v5.0)
Further exclusion criteria apply.