Study of BAY1834942 in Patients With Solid Tumors

• Status: Completed
• Trial end date: 2021-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Antibodies; Immunoglobulin G; Immunoglobulins; Pembrolizumab

Criteria

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