An Exploratory Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ON 123300 Capsules Administered Orally as Escalating Daily Doses in Patients with Advanced Cancer Relapsed or Refractory to at Least One (1) Prior Line of Therapy

MC #21-12

Solid Tumor
Molecular Target(s)
ARK5, CDK4/6, NUAK1 protein
Drug Classification(s)
Small Molecule
ON 123300

Mechanism of Action

ON 123300 is a small molecule, dual inhibitor of CDK4/6 and ARK5, a key enzyme controlling cellular energy homeostasis. Inhibition of ARK5 by ON 123300 collapses oncogene-altered energy metabolism, leading to programmed cell death.


  • About the safety and tolerability of the study drug
  • If the study drug prevents or delays tumor growth or shrinks existing tumors
  • How much of the study drug is absorbed into the blood and how fast it is removed
  • How the study drug is acting in your body



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