ArticleBMC medicine2025
Safety and tolerability of bireociclib for the treatment of advanced solid tumors as monotherapy and in combination with endocrine therapy: a multicenter, open-label, phase 1 clinical trial.
Article in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04539496 (A Multicenter, Open-label Phase I/II Study of XZP-3287 in Metastasis Solid Tumors in China), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Open-label Phase I/II Study of XZP-3287 in Metastasis Solid Tumors in China
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22 authors.
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Abstract
backgroundCyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors have been approved for the treatment of hormone receptor-positive (HR
methodsA multicenter, open-label, phase 1 trial which consisted of two parts. Part 1 evaluated bireociclib monotherapy at doses ranging from 20 mg once-daily (QD) to 480 mg twice-daily (BID), and part 2 evaluated bireociclib at the recommended dosage in combination with endocrine therapy for ABC patients, including bireociclib plus non-steroidal aromatase inhibitor (cohort A), bireociclib plus fulvestrant as first-line (cohort B), or second-line therapy (cohort C). The endpoints included observing dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD), as well as determining recommended phase 2 dosage for a single regimen (RP2D-S) and recommended phase 2 dosage for combination therapy (RP2D-C) and assessment of the general safety and efficacy of therapy.
resultsThirty-five patients were included in the part 1 MTD analysis and no DLTs occurred. Bireociclib 480 mg BID had more stable blood concentration fluctuations as well as a superior tumor response rate (objective response rate [ORR], 17.5%), which was identified as RP2D-S. In part 2, 6 patients each were enrolled in the combination study to assess MTD. One DLT occurred (a grade 3 hepatic enzyme increase), so RP2D-C was determined to be 360 mg BID. The highest incidence of any grade and grade 3 or 4 treatment-emergent adverse events in both part 1 and part 2 were diarrhea, neutropenia, and leukopenia. During the dose expansion phase in part 2, the ORR reached 57.1%, 57.1%, and 46.3% in cohorts A, B, and C, respectively.
conclusionsBireociclib demonstrated favorable efficacy and an acceptable safety profile both as monotherapy (RP2D-S of 480 mg BID) and in combination therapy (RP2D-C of 360 mg BID) for treating HR
trial registrationRegistered with ClinicalTrials.gov, identification ID: NCT04539496, registration date: 03/09/2020 (retrospectively registered).
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