Patients
anomaly, tumor, M1c, toxicities, myelodysplastic syndrome, hypersensitivity
HEPATIC IMPAIRMENT, TUMOR, UNCONTROLLED HYPERTENSION, ACUTE MYELOID LEUKEMIA, BRAIN METASTASES, DISEASE, MYELODYSPLASTIC SYNDROME, VIRAL INFECTION, SOLID TUMOR, VENTRICULAR DYSRHYTHMIA, HYPERSENSITIVITY
A data cutoff date of 22 March 2022 was used for safety and efficacy analyses. Patients in module 1 (Full inclusion criteria included: signature of written informed consent form by the patient or legal guardian; adult aged ≥18 years at the time of consent; ECOG performance status score of 0 or 1; histologically confirmed solid tumor resistant or refractory to standard treatment and/or patients intolerant to standard therapy; measurable disease per RECIST 1.1 (allowance made upon sponsor approval for enrollment of patients without measurable disease if monitorable by tumor markers); provision of archival tumor tissue sample or fresh biopsy; ability to comply with protocol and study procedures; ability to swallow and retain oral medications; acceptable organ and hematologic function at time of screening; negative pregnancy test for women of childbearing potential at time of screening and before first dose; willingness to use highly effective contraception during the study period and 6 months after last dose; resolution of toxicities of prior therapy or surgery; completion of any radiation therapy 7 d before first dose; life expectancy ≥12 weeks after the start of treatment; (M1c only) ability to consume a high-fat meal and fast for 12 h.All eligible patients had deleterious or likely deleterious gene alterations for at least one of the following genes: Patients were not eligible to participate if they met any of the following exclusion criteria: treatment with chemotherapy, small molecule or biologic anti-cancer therapy within 14 d before first dose of study drug; prior therapy with an ATR or DNA-PK inhibitor; history of or current condition, therapy or laboratory anomaly that could compromise patient safety, confound study results or interfere with study participation; known hypersensitivity to any ingredients of camonsertib; uncontrolled, symptomatic brain metastases; uncontrolled hypertension; active, uncontrolled bacterial, fungal or viral infection; moderate or severe hepatic impairment; clinically significant history of abnormal electrocardiogram, history or risk of ventricular dysrhythmias, Fridericia formula for corrected QT interval (QTcF) >470 ms or treatment with medications known to prolong QT interval; history of myelodysplastic syndrome or acute myeloid leukemia; inability to comply with protocol and follow-up procedures; treatment with strong CYP3A inhibitors or inducers, P-gp inhibitors or BCRP inhibitors within 14 d of first dose; and pregnancy or breastfeeding.