G1 Therapeutics has commenced a Phase Ib/II clinical trial investigating G1T38 in combination with Tagrisso (osimertinib) for the treatment of patients with EGFR-mutant (EGFRm) non-small cell lung cancer (NSCLC).
Tagrisso will be supplied by AstraZeneca under a non-exclusive clinical trial collaboration agreement.
Go deeper with GlobalData
The open-label trial will be conducted in two parts; a safety, pharmacokinetic and dose-finding portion and a subsequent randomised portion.
Around 145 subjects are expected to be enrolled in the trial.
Primary endpoints of the trial include safety and tolerability, as well as identifying a recommended Phase II dose and progression-free survival (PFS).
Secondary endpoints will include assessment of pharmacokinetics, tumour response and overall survival (OS) rate.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataG1 Therapeutics R&D senior vice-president and chief medical officer Raj Malik said: “G1T38 inhibits tumour cell growth, providing a rationale for combining it with other targeted therapies, including EGFR-TKI inhibitors such as Tagrisso.
“In a prior Phase Ia trial, G1T38 had no dose-limiting toxicities and was well tolerated with no impact on liver or cardiovascular function, presenting evidence of a favourable safety and tolerability profile for combination therapy.
“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.”
G1T38 is currently under development as a potential oral CDK4/6 inhibitor for use in combination with other targeted therapies in multiple oncology indications.
Apart from the new trial, the solution is being evaluated in a separate Phase I/II clinical trial assessing G1T38 in combination with Faslodex for treating people with estrogen receptor-positive, HER2-negative breast cancer.
