Study of BAY1834942 in Patients With Solid Tumours

Official Title

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

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 tumour response profile of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody BAY1834942 in patients with advanced solid tumours known to have a prevalence for CEACAM6 expression. The study consists of dose escalation and a tumour type-specific expansion.

Trial Description

Primary Outcome:

  • Incidence of treatment-emergent adverse events
  • Severity of treatment-emergent adverse events
  • Cmax of BAY1834942 after single dose
  • AUC(0-504) of BAY1834942 after single dose
Secondary Outcome:
  • AUC(0-504),md of BAY1834942 after multiple doses
  • Cmax,md of BAY1834942 after multiple doses
  • Overall response rate (ORR)
  • Leukocyte immune phenotyping
  • CEACAM6 receptor occupancy
  • Cytokine levels
  • Ex vivo-stimulated cytokine secretion
  • Concentration of carcinoembryonic antigens (CEA; tumour marker) in serum
  • Concentration of anti-drug antibodies
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 tumour response profile, pharmacodynamics, pharmacokinetics and immunogenicity after multiple doses of the drug.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society