The purpose of the study is to test how well patients with advanced solid tumors and ovarian cancer respond to treatment with elimusertib in combination with niraparib. In addition researchers want to find for patients the optimal dose of elimusertib in combination with niraparib, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication elimusertib 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
Elimusertib will be administered in 28-day cycles.
Niraparib will be administered in 28-day cycles.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 30 days after the last administration of study intervention
Severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 30 days after the last administration of study intervention
Incidence of treatment emergent serious adverse events (TESAEs)
Time frame: Up to 30 days after the last administration of study intervention
Severity of treatment emergent serious adverse events (TESAEs)
Time frame: Up to 30 days after the last administration of study intervention
Maximum tolerated dose (MTD): Frequency of Dose Limiting Toxicities (DLTs) at each dose level during the DLT observation period for Cycle 1
Time frame: Cycle 1, 28 days after first administration of study intervention
Recommended Phase II dose (RP2D) of elimusertib
Time frame: Up to 30 days after last administration of study Intervention
Incidence of participants with complete response (CR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with partial response (PR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with stable disease (SD)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with progressive disease (PD)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Objective response rate (ORR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Disease control rate (DCR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Cmax (Maximal plasma exposure) of elimusertib after single dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
AUC(0-8) of elimusertib after single dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
Cmax,md of elimusertib after multiple dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
AUC(0-8)md of elimusertib after multiple dose administration
AUC: Area under the curve
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
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