G1 Therapeutics (Nasdaq:GTHX), a clinical-stage oncology company, today announced that it has initiated a Phase 1b/2 clinical trial assessing G1T38, its oral CDK4/6 inhibitor, in combination with Tagrisso® (osimertinib) in people with EGFR-mutant (EGFRm) non-small cell lung cancer (NSCLC). AstraZeneca (LON: AZN) is providing Tagrisso for this trial under a non-exclusive clinical trial collaboration agreement.
As quoted in the press release:
“G1T38 inhibits tumor cell growth, providing a rationale for combining it with other targeted therapies, including EGFR-TKI inhibitors such as Tagrisso. In a prior Phase 1a trial, G1T38 had no dose-limiting toxicities and was well tolerated with no impact on liver or cardiovascular function, presenting evidence of a favorable safety and tolerability profile for combination therapy,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D of G1 Therapeutics. “Despite advances in care, lung cancer remains the leading cause of cancer death globally. Non-small cell lung cancer represents the majority of lung cancers, and there is a significant need for new treatment options that improve outcomes for people with this disease.”
The open-label trial is expected to enroll approximately 145 participants in two parts: a safety, pharmacokinetic and dose-finding portion (Part 1); and a subsequent randomized portion (Part 2). Primary outcome measures include safety and tolerability, identifying a recommended Phase 2 dose and progression-free survival (PFS). Secondary outcome measures include assessment of pharmacokinetics, tumor response and overall survival (OS).