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Kronos Bio to Start Phase I/II CDK9 Inhibitor Study in MYC-Amplified Solid Tumors

NEW YORK – The US Food and Drug Administration has accepted Kronos Bio's investigational new drug application for its CDK9 inhibitor KB-0742, allowing the firm to begin clinical trials in MYC-amplified advanced solid tumors in the first quarter of 2021.

The Phase I/II study will involve a dose escalation and expansion stage. In the dose escalation stage, researchers will evaluate the safety, pharmacokinetic, and pharmacodynamic profile of KB-0742, and settle on an active and safe dose for further evaluation. In the second stage, the KB-0742 dose established in the earlier stage will be given to patients with MYC-amplified solid tumors and other rare tumors, including sarcomas and chordomas, relying on MYC overproduction for proliferation.

MYC is amplified in 30 percent of solid tumors. San Mateo, California-based Kronos said in a statement that it expects to report initial data from the dose escalation stage of the Phase I/II trial sometime next year.