Clinical-stage pharmaceutical firm G1 Therapeutics has commenced two Phase Ib / IIa trials of the CDK4 / 6 inhibitor G1T28 in patients with small-cell lung cancer (SCLC).
G1T28 is an intravenous (IV) therapy, which will be studied as a bone marrow and immune system chemoprotectant in patients with SCLC who are receiving chemotherapy.
The studies include an 80-patient randomised first-line study (02 Study) and a 40-patient single-arm second / third-line study (03 Study).
G1 Therapeutics CEO Mark Velleca said: "G1T28 is a first-in-class approach that could change the oncology treatment paradigm by mitigating myelosuppression and improving tumour responses and health outcomes.
"We believe that G1T28 could obviate the need for haematopoietic growth factors and has the potential to become part of emerging treatment regimens that combine chemotherapy with immune system modulation."
The 02 Study is a multi-centre randomised and placebo-controlled study that will assess the potential clinical benefit of G1T28 when administered IV just prior to standard doses of carboplatin and etoposide as a first-line treatment for patients with newly diagnosed extensive-stage SCLC.
Its outcome measurements comprise assessment of haematologic parameters and toxicities, infections, chemotherapy dose reductions, utilisation of growth factors and blood transfusions, and assessment of anti-tumour activity.
The 03 Study is a multi-centre single-arm study that will evaluate the potential clinical benefit of G1T28 when administered IV just prior to standard doses of topotecan in patients previously treated for extensive-stage SCLC.
Its outcome measurements also comprise haematologic parameters and toxicities, infections, chemotherapy dose reductions, utilisation of growth factors and blood transfusions, and assessment of anti-tumour activity.
Image: Micrograph of small cell carinoma of the lung, also known as small cell lung cancer. Photo: courtesy of Nephron.