ArticleThe oncologist2025
Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors.
Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05905614 (An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
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No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
8 authors.
Funding
Abstract
backgroundPreclinical models demonstrated promising anti-tumor activity of SPH4336, a novel oral, highly selective cyclin-dependent kinase (CDK) 4/6 inhibitor.
methodsThis phase I study enrolled patients who received SPH4336 orally in 6 dose-escalation cohorts (50-600 mg) in a 3 + 3 design. Based on tolerability, pharmacokinetics (PK) and activity data from the dose-escalation phase, 2-3 dose cohorts were expanded. Dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), efficacy, safety, tolerability, and pharmacokinetics (PK) were investigated.
resultsA total of 29 patients with breast cancer (BC) (n = 14), sarcoma (n = 8), non-small cell lung cancer (n = 2) and others (n = 5) were enrolled. Neither DLT nor MTD were reached. All patients had at least one treatment-related adverse events (TRAEs), most of which were grade 1/2. Grade ≥ 3 TRAEs occurred in 51.7% of patients. One patient died from disease progression and five reported serious adverse events. Plasma concentrations increased dose-dependently, except at 600 mg, and steady state was reached at 2 weeks for 400 mg. One BC patient in the 600-mg cohort had a confirmed partial response. The disease control rate was 59.3% (95% CI, 38.8-77.6).
conclusionSPH4336 demonstrated an acceptable safety profile and dose-dependent plasma exposure in patients with various advanced solid tumors. (ClinicalTrials.gov Identifier: NCT05905614; IRB Approved.).
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