Metastatic Malignant Solid Neoplasm Clinical Trial
Official title:
Strategic Alliance: Phase 1b Trial of the Combination of the ATR Inhibitor BAY1895344 and PI3K Inhibitor Copanlisib in Molecularly Selected Patients With Advanced Solid Tumors (COPABAY)
This phase Ib trial finds out the best dose, possible benefits and/or side effects of BAY1895344 and copanlisib in treating molecularly selected patients with solid tumors that have spread to other places in the body (advanced). BAY1895344 and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving BAY1895344 and copanlisib together may help control the progression of the disease in patients with advanced solid tumors.
PRIMARY OBJECTIVE: I. To evaluate the safety and determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of the combination of copanlisib and elimusertib (BAY1895344) in patients with molecularly-selected advanced solid tumors. SECONDARY OBJECTIVES: I. To assess clinical benefit of copanlisib in combination with BAY1895344 in patients with molecularly-selected advanced solid tumors. II. To assess the pharmacokinetic and pharmacodynamic profile of the combination of copanlisib and BAY1895344. III. To assess predictive biomarkers of response and resistance to the combination of copanlisib and BAY1895344, as well as pharmacodynamic (PD) biomarkers. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 arms. ARM I (SEQUENTIAL): Patients receive elimusertib orally (PO) twice daily (BID) on days 1-3 and 15-17, and copanlisib intravenously (IV) over 1 hour on days 4 and 18. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive elimusertib PO BID and copanlisib IV at the discretion of the treating physician. ARM II (CONCOMITANT): Patients receive elimusertib PO BID on days 1-3 and 15-17, and copanlisib IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive elimusertib PO BID and copanlisib IV at the discretion of the treating physician. After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 2 years. ;
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