Study of BAY1834942 in Patients With Solid Tumors

Status: Active

Description

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).

Eligibility 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 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 & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Bayer Corporation

Trial IDs

Primary ID 18650
Secondary IDs NCI-2019-02588, 2018-002561-19
Clinicaltrials.gov ID NCT03596372