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.

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03596372.

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.

Trial PhasePhase I

Trial Typetreatment

Lead OrganizationBayer Corporation

Primary ID18650
Secondary IDsNCI-2019-02588, 2018-002561-19
ClinicalTrials.gov IDNCT03596372

Study of BAY1834942 in Patients With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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Study of BAY1834942 in Patients With Solid Tumors

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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