Trial Condition(s):

Advanced CEACAM6-expressing solid tumors

Study of BAY1834942 in patients with solid tumors

Bayer Identifier:

18650

ClinicalTrials.gov Identifier:

NCT03596372

EudraCT Number:

2018-002561-19

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1834942
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Completed
 
Locations

Sarah Cannon Research Institute

Nashville, United States, 37203

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119074

Status
Completed
 
Locations

Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

Status
Completed
 

Trial Design