ATR Inhibitor BAY 1895344 Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

STATUS

Recruiting
participants needed

56
sponsor

Bayer

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Updated on 19 February 2024

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cancer

platelet count

serum pregnancy test

measurable disease

metastasis

solid tumour

neutrophil count

niraparib

fallopian tube

ovarian cancer

primary peritoneal carcinoma

peritoneal cancer

tumor cells

malnutrition

line of therapy

muga scan

ATR

prostate cancer

Summary

The purpose of the study is to test how well patients with advanced solid tumors and ovarian cancer respond to treatment with BAY1895344 in combination with niraparib. In addition researchers want to find for patients the optimal dose of BAY1895344 in combination with niraparib, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication BAY1895344 works by blocking a substance produced by the body (ATR Kinase) which is important for the growth of tumor cells. Niraparib works by blocking a substance produced by the body (PARP enzymes) in a way that tumor cells can be killed, or made more susceptible to chemotherapy.

Details

Condition	Ovarian disorder, Ovarian Cancer, Ovarian Cancer, Advanced Solid Tumors
Age	18-100 years
Treatment	Niraparib, BAY1895344
Clinical Study Identifier	NCT04267939
Sponsor	Bayer
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Participant must be 18 years of age, at the time of signing the informed consent
	Participants must have histologically confirmed diagnosis of the following indications as described below
	\-- Dose escalation (Part A): recurrent advanced solid tumors, excluding
	prostate cancer, who experienced disease progression after treatment with all
	available standard of care therapies for metastatic disease Participants must
	have DDR deficiency in their tumors. -- Dose expansion (Part B): recurrent
	EOC, fallopian tube or primary peritoneal cancer
	Sub-population 1: participants PARPi nave and with a platinum-resistant/refractory disease (recurrence with a PFI < 6 months from last platinum-based regimen). Participants may not have had more than 3 prior therapies since the development of platinum resistance
	Sub-population 2: participants with disease progression on PARPi (including niraparib), administered as maintenance as well active line of therapy. Participants must have not received further line of therapy after disease progression on PARPi
	Participants in Part A and sub-population 1of part B of the study will need to have DDR deficiency in their tumors.Sub-population 2 of Part B will be BM unselected (BM analysis only retrospective)
	Participants must have disease progression and measurable disease, as defined by RECIST 1.1
	Archival tissue must not be older than 12 months, otherwise fresh tumor tissue samples at baseline are mandatory
	ECOG PS of 0 to 1
	Life expectancy of at least 12 weeks
	Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 ( 2) days before the first dose of study intervention
	Hemoglobin (Hb) 10 g/dL
	Platelet count 150 x 109/L ( 150,000/mm3)
	Absolute neutrophil count (ANC) 2.0 x 109/L ( 2000/mm3)
	Participants must have adequate organ function
	Participants must have adequate coagulation
	Adequate cardiac function per institutional normal measured by echocardiography (recommended) or MUGA scan/cardiac MRI per institutional guidelines
	A female participant is eligible to participate if she is not pregnant (confirmed by a negative serum pregnancy test within 7(2)days of first study intervention), not breastfeeding, or is not a woman of childbearing potential (WOCBP). Participants must agree to use highly effective contraception during the intervention period and for at least 6 months (180 days) after intervention
Exclusion Criteria
	Inability to swallow oral medication
	Known hypersensitivity to BAY1895344 and/or niraparib or excipients of the preparations or any agent given in association with this study
	History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
	Ongoing or active uncontrolled infection (bacterial, fungal, or viral; e.g. hepatitis viral) of CTCAE grade 2 that requires systemic treatment
	Known history of HIV infection (HIV 1/2 antibodies)
	Immunocompromised participants (e.g. diagnosis of immunodeficiency or ongoing immunosuppressive therapy)
	Pleural effusion or ascites that causes respiratory compromise (CTCAE grade 2 dyspnea)
	Active HBV or HCV infection that requires treatment
	Moderate or severe hepatic impairment, i.e. Child Pugh Class B or C
	Participants with significant cardiovascular disease and/or relevant findings are
	excluded
	History of cardiac disease: congestive heart failure 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)
	Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex 120 ms, or prolongation of the of the QTc interval (Fridericia) over 450 ms unless agreed otherwise between the investigator and the sponsor's medically responsible person
	Previous treatment with an ATR Inhibitor
	Previous treatment with known or putative PARPi, if discontinued for CTCAE grade 3 AEs or CTCAE grade 3 hypersensitivity to PARPi

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ATR Inhibitor BAY 1895344 Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer