Study of BAY1834942 in Patients With Solid Tumors

The primary objectives of the study are to evaluate and characterize the tolerability and
safety profile of repeated doses of BAY1834942 alone or in combination with pembrolizumab,
and to characterize the pharmacokinetics of BAY1834942 alone or in combination with
pembrolizumab after single dose.

Secondary objectives are to evaluate the tumor response profile, pharmacodynamics and
pharmacokinetics after multiple doses of the drug.

Inclusion Criteria:

- Male or female patients aged ≥ 18 years

- Patients with histologically confirmed advanced/ metastatic solid tumors: Dose
escalation: solid tumor types with a expression of CEACAM6 (gastric/ GEJ cancer,
esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer,
bladder cancer, head and neck squamous cell cancer, bile duct cancer); Dose expansion:
advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma.

- ECOG-PS of 0 to 1.

- Adequate organ function (bone marrow, liver, kidneys).

- Adequate coagulation function.

- Adequate cardiac function

Exclusion Criteria:

- Patients with active symptomatic or untreated brain metastases; possible exceptions
for patients with treated asymptomatic central nervous system metastases

- Active autoimmune disease

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis

- Risk factors for bowel obstruction or bowel perforation

- History of cardiac disease

- Uncontrolled arterial hypertension despite optimal medical management

- Clinically relevant findings in electrocardiogram

- HIV infection

- Active HBV or HCV infection