Study of BAY1834942 in Patients With Solid Tumors
Study of BAY1834942 in Patients With Solid Tumors
This is an open-label, Phase 1, first-in-human, dose escalation and expansion study designed
 to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and tumor response
 profile of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6)
 antibody BAY1834942 in patients with advanced solid tumors known to have a prevalence for
 CEACAM6 expression.

 The study consists of dose escalation and a tumor type-specific expansion.
The primary objectives of the study are to evaluate and characterize the tolerability and
 safety profile of repeated doses of BAY1834942, and to characterize the pharmacokinetics of
 BAY1834942 after single dose.

 Secondary objectives are to evaluate the tumor response profile, pharmacodynamics,
 pharmacokinetics and immunogenicity 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 or evidence of active pulmonary fibrosis, organizing pneumonia, or
 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