Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion

Description

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 tumor type-specific expansion in which BAY1834942 will be administered either alone (monotherapy) or in combination with pembrolizumab (combination therapy).

Official Title

An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the Anti-CEACAM6 Antibody BAY1834942 in Patients With Advanced Solid Tumors

Details

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.

Keywords

Advanced CEACAM6-expressing Solid Tumors First-in-human Immuno-oncology CEACAM6 Checkpoint Inhibition Monotherapy Combination therapy Pembrolizumab Antibodies Immunoglobulins Immunoglobulin G BAY1834942 BAY1834942 + Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC Davis Comprehensive Cancer Center not yet accepting patients
    Sacramento California 95817 United States
  • Cedars-Sinai not yet accepting patients
    Beverly Hills California 90211 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
ID
NCT03596372
Phase
Phase 1
Study Type
Interventional
Last Updated