Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors.

ABSTRACT:

Background

Preclinical models demonstrated promising anti-tumor activity of SPH4336, a novel oral, highly selective cyclin-dependent kinase (CDK) 4/6 inhibitor.

Methods

This 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.

Results

A 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. A

SUBMITTER: Jiang Y 

PROVIDER: S-EPMC12207880 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature