Carrick Therapeutics Inc. has announced the dosing of the first patient in a Phase 1 clinical trial evaluating CT7439, a novel cyclin-dependent kinase 12/13 (CDK12/13) inhibitor and Cyclin-K glue-degrader, for advanced solid tumors. The trial, identified as NCT06600789 on clinicaltrials.gov, is designed to assess the safety, pharmacokinetics, and early signs of efficacy of CT7439 in patients with cancers including ovarian, breast, and Ewing's Sarcoma.
CT7439: A Novel Approach to DNA Repair Inhibition
CT7439 is designed to inhibit CDK12/13 and degrade Cyclin-K, the obligate co-factor for CDK12/13. This dual mechanism aims to enhance the potency of the compound and inhibit DNA repair at the transcriptional level. CDK12/13 regulates gene transcription through the activation of RNA Polymerase II. By inhibiting CDK12/13, CT7439 has the potential to synergize with other DNA damage response (DDR) targeting agents, such as PARP inhibitors.
Phase 1 Trial Design and Objectives
The Phase 1 clinical trial employs a modular design, commencing with a dose escalation phase to evaluate the safety and pharmacokinetics of CT7439. The trial will also explore early proof of principle using a blood-based pharmacodynamic assay of the homologous recombination repair (HRR) pathway. The study aims to enroll patients with advanced solid tumors, including ovarian, breast, and Ewing's Sarcoma, which often exhibit aggressive and resistant characteristics.
Executive Perspective
"Initiation of our CT7439 Phase 1 clinical trial marks the advancement of our second therapeutic into the clinic for aggressive and resistant forms of cancer," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "CT7439 is the first CDK12/13 inhibitor to enter clinical development, and we are encouraged by its potential as monotherapy or combination therapy across multiple tumor types."
