A clinical study to test the safety and efficacy of GB1211 in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC).

Phase 1

• Conditions: 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).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003189-11-IT
• Lead Sponsor: Galecto Biotech AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-13
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Must be = 18 years of age at the time of signing the Informed Consent Form (ICF).
2. Must provide signed ICF.
3. Must have the ability to comply with the study protocol, in the investigator’s judgment.
4. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agree to refrain from donating eggs.
5. Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agree to refrain from donating sperm.
6. Diagnosed NSCLC with adenocarcinoma and its variants according to the 2015 WHO classification.
7. Measurable disease, as defined by RECIST v1.1.
8. Have histologically or cytologically confirmed advanced or metastatic NSCLC defined as: Stage IIIB that either progressed after curative therapy or is not candidate to curative therapy, or Stage IV metastatic disease.
9. Expressing PD-L1 on at least 50% of tumour cells.
10. Agree to have a tumour biopsy that is eligible for Gal-3 expression evaluation before the first study drug dose.
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
12. Have not received prior systemic chemotherapy for the treatment of recurrent, advanced or metastatic disease, treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 4 weeks prior to diagnosis of recurrent advanced or metastatic disease.
13. Patients must not have received immune checkpoint inhibitors previously.
14. Must be eligible for atezolizumab at 1200 mg every 3 weeks as defined in the atezolizumab product label.
15. Patients receiving therapeutic anticoagulation must be on stable regimen.
16. Adequate haematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• Absolute neutrophil count (ANC) = 1.5 × 109/L (1500/µL) without granulocyte colony-stimulating factor support.
• Lymphocyte count = 0.5 × 109/L (500/µL).
• Platelet count = 100 × 109/L (100,000/µL) without transfusion.
• Haemoglobin = 90 g/L (9 g/dL). Patients may be transfused to meet this criterion.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 2.5 × upper limit of normal (ULN), with the following exceptions:
o Patients with documented liver metastases: AST and ALT = 5 × ULN.
o Patients with documented liver or bone metastases: ALP = 5 × ULN.
• Total bilirubin = 1.5 × ULN with the following exception:
Patients with known Gilbert disease: total bilirubin = 3 × ULN.
• Creatinine clearance = 50 mL/min (calculated using the Cockcroft-Gault formula).
• Albumin = 25 g/L (2.5 g/dL).
• For patients not receiving therapeutic anticoagulation: INR and a PTT = 1.5 × ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

2. Patients with known hypersensitivity to GB1211 or any of the excipients.
6. Life expectancy = 12 weeks.
9. Diagnosed NSCLC with squamous cell carcinoma.
16. 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.
18. Patients with acute neurological events (e.g., intracranial or subarachnoid haemorrhage, stroke, intracranial trauma) within 6 months of inclusion.
19. Patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases confirmed by a CT or MRI scan.
21. History of malignancy other than NSCLC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate = 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
22. Patients with past medical history or any evidence of clinically active interstitial lung disease, including drug-induced interstitial lung disease.
23. Uncontrolled significant pleural effusion.
24. History of non-infectious pneumonitis that required steroids or current pneumonitis.
26. Patients with a history of arrhythmia, especially ventricular arrhythmias, atrial fibrillation or recent recovery of rhythm after atrial fibrillation.
27. Patients with bradycardia (<50 beats per minute).
28. Patients with left ventricular ejection fraction (LVEF) of =40%.
29. Patients with a family history of sudden cardiac death before the age of 50.
30. Patients with a QT/QTc interval > 470 ms (for women) and > 450 ms (for men) at screening or congenital long QT syndrome.
31. Patients with electrolyte imbalances: hypokalaemia, hypomagnesemia, or hypocalcaemia.
32. Patients with history of organ transplant or hematopoietic stem cell transplantation.
36. Patients who have received GB1211 prior to this study.
38. Surgery within 3 weeks before the study.
42. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.
43. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor-a [TNF-a] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified