First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas



Status:Recruiting
Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:July 6, 2017
End Date:June 2, 2020
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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An Open-label, First-in-human, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose and / or Recommended Phase II Dose of the ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas

The ATR(ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for
the treatment of patients with advanced solid tumors and lymphomas. The purpose of the
proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the
maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further,
the response of the cancer to the treatment will be determined.


Inclusion Criteria:

Part A - single-agent dose-escalation part:

- Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma (NHL).

J-arm of Part A - single-agent doseescalation in Japanese

- Japanese patients with histologically confirmed solid tumors. Patients with tumors known
to be positive for DDR (deoxyribonucleic acid damage repair) defects (such as ATM
(ataxia-telangiectasia mutated) deleterious mutation or low ATM expression) can be
included.

Part B - single-agent expansion part:

- Patients with DDR deficiency biomarker-positive advanced solid tumors of the following
histologies: i) CRPC (castration-resistant prostate cancer); ii) HER2-negative BC that
is hormone-receptor positive (estrogen-receptor positive, progesterone-receptor
positive, or both) or TNBC (triple negative BC); iii) CRC (colorectal cancer), and iv)
gynecological tumors (ovarian, primary peritoneal, and fallopian tube cancers,
endometrial cancer, or cervical cancer). The biomarker status of patients in Part B
will be evaluated before general screening and only patients with the presence of the
putative biomarkers of DDR deficiency will be recruited into general screening.

- Patients with histologically confirmed advanced cancer and loss of ATM protein by IHC,
regardless of the cancer type.

The following inclusion criteria apply to ALL (dose-escalation and expansion) patients:

- Patients with tumors resistant or refractory to standard treatment and in which, in
the opinion of the investigator, experimental treatment with BAY1895344 may be of
benefit, Furthermore, no standard therapy would confer clinical benefit to the
patient.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Patients must have adequate bone marrow function as assessed by the following
laboratory tests to be conducted within 7 (±2) days before the first dose of study
drug:

1. Hemoglobin ≥ 8.5 g/dL; patients with chronic erythropoietin treatment consistent
with institutional guidelines can be included.

2. Absolute neutrophil count (ANC) ≥ 1.5X10* 9/L (≥ 1500/mm3)

3. Platelet count ≥ 100X10*9/L (≥100,000/mm3)

Exclusion Criteria:

- Known hypersensitivity to the study drugs or excipients of the preparations or any
agent given in association with this study

- History of cardiac disease: congestive heart failure New York Heart Association (NYHA)
class >II, unstable angina (angina symptoms at rest), new-onset angina (within the
past 6 months before study entry), myocardial infarction within the past 6 months
before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta
blockers, calcium channel blockers, and digoxin are permitted)

- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C

- Patients with known human immunodeficiency virus (HIV) infection

- Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection requiring treatment. Patients with chronic HBV or HCV infection are eligible
at the investigator's discretion provided that the disease is stable and sufficiently
controlled under treatment.

- Infections of CTCAE(Common Terminology Criteria for Adverse Events Version) Grade 2
not responding to therapy or active clinically serious infections of CTCAE Grade >2
We found this trial at
12
sites
4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Canton, OH
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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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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Salt Lake City, UT
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Cleveland, OH
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Edmonton, Alberta
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Edmonton,
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Fairfax, VA
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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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Houston, TX
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New York, New York 10021
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New York, NY
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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San Antonio, Texas 78217
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San Antonio, TX
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