A phase 2a trial is kicking off to study frontline GB1211 with the immunotherapy agent Tecentriq in patients with advanced or metastatic non-small cell lung cancer.
The first patient has been enrolled in the phase 2a GALLANT-1 clinical trial, testing the novel agent GB1211 with the immunotherapy agent Tecentriq (atezolizumab) for patients with advanced or metastatic non-small cell lung cancer that has not previously been treated.
GALLANT-1 will be conducted in two parts: Part A will be open-label (meaning that both patients and clinicians will know what treatment is being administered) in eight to 12 patients, with the goal of determining the proper dosage (200 mg or 400 mg) of GB1211 in this patient population. Then, Part B, which will be blinded, will analyze safety, efficacy (how much the tumors shrink), clinical activities and immune biomarkers of the drug duo.
GB1211 targets the galectin-3 protein, which is linked to tumor growth, invasiveness and the potential for the disease to metastasize (spread throughout the body). Galectin-3 also can contribute to the suppression of T-cell function and protection of tumor cells, thereby allowing cancer cells to escape from immune cells that may otherwise kill them.
While prior research has linked galectin-3 levels may also lead to resistance to immune checkpoint inhibitors, pre-clinical research of GB1211 showed that it may increase the efficacy of checkpoint inhibition, while also shrinking tumors.
“We are very excited about the potential use of our proprietary compounds in difficult-to-treat cancers. GB1211 has been shown to be a well-tolerated, potent inhibitor of galectin-3 with the potential to act as a monotherapy in solid tumors and enhance checkpoint inhibitor therapies,” Dr. Hans Schambye, CEO of Galecto (the manufacturer of GB1211), said in a press release.
The study is still recruiting participants. In order to be eligible, an individual must be over the age of 18, diagnosed with advanced or metastatic non-small cell clung cancer. Patients must have PD-L1 expression on 50% or more of their tumor cells, be able to perform activities of daily living with no or minimal assistance (ECOG performance status of 0 or 1), have no received prior checkpoint inhibition and have adequate organ function.
Galecto anticipates early data from the trial to be available some time in the middle of 2023.
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