ArticleClinical cancer research : an official journal of the American Association for Cancer Research2026
Phase I Study of Rogocekib in Patients with Advanced, Relapsed, or Refractory Malignant Solid Tumors.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeAberrant splicing plays a significant role in cancer progression, yet targeted treatments are lacking. Rogocekib (developmental name CTX-712) is a potent oral inhibitor of CDC2-like kinase that targets RNA splicing. This phase I study aimed to evaluate the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD) profiles, preliminary efficacy, and the recommended dose of rogocekib in patients with advanced solid tumors. PATIENTS AND
methodsThe dose escalation started with an accelerated titration phase and then transitioned to a 3 + 3 design at doses ranging from 10 to 175 mg, administered twice weekly. For dose expansion, 105 mg twice weekly, 70 mg twice weekly, and 105 mg once weekly were investigated.
resultsIn total, 46 patients with solid tumors were administered rogocekib. The MTD was determined to be 140 mg twice weekly. DLTs were observed in one patient at 140 mg twice weekly (platelet count decreased and hypokalemia) and in one patient at 175 mg twice weekly (dehydration). Common related adverse events included nausea, vomiting, and diarrhea. Two treatment-related deaths were observed. PK analysis showed a dose-dependent increase in systemic exposure to rogocekib. PD analysis of two markers (THAP9-AS1 and S6K) showed target engagement of rogocekib. A partial response was observed in 6.5% of patients, all with ovarian cancer (n = 3).
conclusionsAlthough most toxicities were manageable, two treatment-related deaths were observed, underscoring the need for vigilant safety monitoring. Overall, rogocekib demonstrated evidence of target engagement in most patients with solid tumors and preliminary antitumor activity, warranting further clinical investigation.
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