ATR Inhibitor BAY 1895344 plus pembrolizumab in advanced solid tumors (GI, Pancreatic, mCRPC, NSCLC)

  • STATUS
    Recruiting
  • sponsor
    Bayer
Updated on 13 October 2021
measurable disease
pembrolizumab
EGFR

Summary

This clinical study aims to investigate if impairment of the deoxyribonucleic acid damage repair (DDR) pathway by the Elimusertib in combination with blockade of the PD-1/PD-L1 pathway by pembrolizumab, may improve antitumor responses in advanced cancer patients with DDR aberrations, at an acceptable safety profile and an expected positive benefit/risk ratio.

Description


Details
Condition Pancreatic Cancer, Gastric Cancer, Prostate Cancer, nsclc
Clinical Study IdentifierTX279019
SponsorBayer
Last Modified on13 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
Presence of the putative biomarkers of DDR deficiency in tumor and/or other tissues
Participants must have histologically confirmed solid tumors
Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
Adequate bone marrow function as assessed by laboratory tests to be conducted within 7 days before the first dose of study intervention
Participants must have adequate kidney function, as assessed by the estimated glomerular filtration rate (eGFR) > 40 mL/min per 1.73 m2 within 7 days before the first dose of study intervention
Participants must have adequate liver function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study intervention
Participants must have adequate coagulation, as assessed by laboratory tests as applicable, (to be conducted within 7 days before the first dose of study intervention) or on stable anti-coagulation treatment
Adequate cardiac function per institutional normal measured by echocardiography (recommended) or multigated acquisition (MUGA) scan/cardiac MRI per institutional guidelines
Participants must have measurable disease (at least one measurable lesion) as per RECIST 1.1, or evaluable disease according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) classification as applicable. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

Exclusion Criteria

Ongoing infections of Common terminology criteria for adverse events (CTCAE) grade ≥2 not responding to therapy or active clinically serious infections
Participants with
a.) Known human immunodeficiency virus (HIV)
b.) Active Hepatitis B infection (positive for Hepatitis B surface antigen (HBsAg)/ Hepatitis B virus (HBV) DNA)
c.) Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay)
Active autoimmune disease (active defined as having autoimmune disease related symptoms and detectable autoantibodies) that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Diagnosis of immunodeficiency or participant is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor
Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade ≥ 2 dyspnea)
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)
Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C. 9. History of organ allograft transplantation 10. Evidence or history of bleeding disorder, i.e., any hemorrhage / bleeding event of CTCAE Grade > 2 within 4 weeks before the first dose of study intervention
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note