A Study to Investigate the Safety and Efficacy of GB1211 (a Galectin-3 Inhibitor) in Combination With Atezolizumab in Patients With Non-Small Cell Lung Cancer (NSCLC).

Patients who meet any of the following criteria will be excluded from study participation.

1. Known contraindications for treatment with PD-1/PD-L1 inhibitors.

2. Patients with known hypersensitivity to GB1211 or any of the excipients.

3. Women who are pregnant or breast-feeding or intending to become pregnant during study treatment or within 9 months after the final dose of study treatment.

4. Women of childbearing potential without a negative serum pregnancy test result within 14 days prior to initiation of study treatment.

5. Women of child-bearing potential or men who are unwilling to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during the study, and do not agree to refrain from donating sperm or egg cells from the first dose of study drug up to 9 months after the last dose of study drug.

6. Life expectancy ≤ 12 weeks from the expected start of study treatment date.

7. Patients who, in the opinion of the investigator (or designee), should not participate in this study.

8. Patients who participated in a clinical research study involving a new chemical entity or an experimental drug ≤ 4 weeks or 5 half-lives before the first dose of study drug.

9. Presence of oncogenes EGFR (exon 19 deletions, pL858R point mutation in exon 21), or ALK rearrangements.

10. Hepatic impairment of Child Pugh B or C.

11. Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test result at screening) and/or hepatitis C virus (HCV).

12. Patients with active human immunodeficiency virus (HIV).

13. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:

* Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.

* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

* Rash must cover \< 10% of body surface area.

* Disease is well controlled at baseline and requires only low-potency topical corticosteroids.

* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.

14. Patients with severe infection within 4 weeks prior to initiation of study treatment.

15. Patients with acute neurological events (e.g., intracranial or subarachnoid haemorrhage, stroke, intracranial trauma) within 6 months of inclusion.

16. Patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. A CT (with contrast if not contraindicated) or MRI scan of the head must be done at screening to evaluate CNS metastasis in all patients. An MRI scan of the brain is required to confirm or refute the diagnosis of CNS metastases at baseline in the event of an equivocal scan.

17. No tumour specimen, obtained in the last 6 months, is available to analyse galectin expression and it is not feasible to obtain a new specimen (note: cytology samples are admissible).

What this study is about