Study of BAY1834942 in Patients With Solid Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:June 19, 2018
End Date:December 13, 2021
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

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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

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).

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.

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
We found this trial at
15
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Oklahoma City, Oklahoma 73104
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Beverly Hills, California 90211
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Calgary, Alberta
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303 East Superior Street
Chicago, Illinois 60611
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Louisville, Kentucky 40207
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Minneapolis, Minnesota 55455
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Tucson, Arizona 85724
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