A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2 * What medical issues/symptoms do participants experience when taking NKT5097
• Able to provide written informed consent
• Advanced unresectable or metastatic solid tumor
• Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
• Measurable or evaluable disease (Part 1 \& 2 only)
• Eighteen years of age or older
• ECOG status of 0 or 1
• Adequate organ function
• Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
• Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
• Able to swallow oral meds
• Willing to provide tumor tissue