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).

NCT05240131 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: GALLANT-1
• Study Type: interventional
• Target: 88
• Locations: 3 countries
• Sites: 5

Brief Summary

This study is an open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension 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).

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• PART A - To assess the safety and tolerability of GB1211 in combination with atezolizumab.

  Incidence and severity of adverse events as reported by investigators.

  3 weeks

• PART B - To assess the safety and tolerability of GB1211 in combination with atezolizumab compared to atezolizumab and placebo

  Incidence and severity of adverse events

  12 weeks

• Part B -To assess the efficacy of GB1211 compared to placebo by measuring the change of the longest diameters of target lesions at week 12.

  Independent central review of CT, PET/CT or MRI scan according to RECIST 1.1

  12 weeks

• Part C - To assess the long-term safety and tolerability of GB1211 in combination with atezolizumab compared to atezolizumab alone.

  Incidence and severity of adverse events.

  12 - 40 weeks

Secondary Outcomes (6)

• Part A -To determine the recommended dose (200 mg BID or 100 mg BID) of GB1211 in combination with atezolizumab.

  3 weeks

• Part A and B - To assess response rate according to RECIST v1.1 of GB1211 versus placebo in combination with atezolizumab.

  12 weeks

• To measure the maximum plasma concentration of GB1211 (Cmax)

  12 weeks

• To measure the time of maximum plasma concentration of GB1211 (Tmax)

  12 weeks

• To measure the area under the concentration-time curve of GB1211 (AUC)

  12 weeks

Study Arms (3)

Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab.

EXPERIMENTAL

Part A of the study, open-label sentinel dosing will be undertaken to assess safety and tolerability of GB1211 at 200 mg and 100 mg BID in combination with atezolizumab.

Drug: GB1211; Drug: Atezolizumab

Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab

EXPERIMENTAL

Part B of the study, GB1211 (200 or 100 mg BID to be selected from part A) in addition to atezolizumab, for 12 weeks

Drug: GB1211; Drug: Placebo; Drug: Atezolizumab

Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab

EXPERIMENTAL

Extension of GB1211 in addition to atezolizumab until part B has been unblinded. Extension of placebo in addition to atezolizumab until part B has been unblinded

Drug: GB1211; Drug: Placebo; Drug: Atezolizumab

Interventions

GB1211 DRUG

GB1211 is a galectin 3 inhibitor an orally available small molecular anti-fibrotic. It is administered orally twice a day.

Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab.; Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab; Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab

Placebo DRUG

Placebo is administered orally twice a day.

Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab; Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab

Atezolizumab DRUG

Atezolizumab is an PD-L1 inhibitor administered as an intravenous infusion every three weeks at a dose of 1200mg

Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab.; Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab; Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet the following criteria for study entry:
• Must be ≥ 18 years of age at the time of signing the Informed Consent Form (ICF).
• Must provide signed ICF.
• Must have the ability to comply with the study protocol, in the investigator's judgment.
• Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agree to refrain from donating eggs.
• Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agree to refrain from donating sperm.
• Diagnosed NSCLC stage IIIB that either progressed after curative therapy (chemoradiation and/or surgery) or is not candidate to curative therapy, or Stage IV metastatic disease (de novo or distant relapse) \[According to UICC TNM edition 8\].
• Measurable disease, as defined by RECIST v1.1.
• Expressing PD-L1 on at least 50% of tumour cells (PD-L1 stained ≥ 50% of tumour cells \[TC ≥ 50%\] or PD-L1 stained tumour-infiltrating immune cells \[IC\] covering ≥ 10% of the tumour area \[IC ≥ 10%\]), as determined through use of the Dako PD-L1 IHC 22C3 pharmDx assay or the Ventana PD-L1 IHC SP263 assay.
• Agree to have a tumour biopsy that is eligible for Gal-3 expression evaluation before the first study drug dose.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• 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.
• Patients must not have received immune checkpoint inhibitors (ICI) previously.
• Must be eligible for atezolizumab at 1200 mg every 3 weeks as defined in the atezolizumab product label.
• Patients receiving therapeutic anticoagulation must be on stable regimen.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study participation.
• Known contraindications for treatment with PD-1/PD-L1 inhibitors.
• Patients with known hypersensitivity to GB1211 or any of the excipients.
• 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.
• Women of childbearing potential without a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
• 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.
• Life expectancy ≤ 12 weeks from the expected start of study treatment date.
• Patients who, in the opinion of the investigator (or designee), should not participate in this study.
• 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.
• Presence of oncogenes EGFR (exon 19 deletions, pL858R point mutation in exon 21), or ALK rearrangements.
• Hepatic impairment of Child Pugh B or C.
• 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).
• Patients with active human immunodeficiency virus (HIV).
• 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.

Sponsors & Collaborators

• Galecto Biotech AB: lead
• Linical Europe GmbH: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (5)

Centre Georges Grancois Leclerc

Dijon, 21000, France

Location

CHRU

Tours, 37044, France

Location

Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc

Olsztyn, 10-357, Poland

Location

Hospital Universitario y Politécnico La Fe

Valencia, València, 46026, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francois Ghiringhelli, MD

  Centre Georges Grancois Leclerc, Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PART A open label PART B \& C will be double blind until the primary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A is an open label dose ascending design. PART B is a randomised, double-blind, placebo-controlled, parallel group design PART C is an extension study to assess long-term safety and tolerability

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 15, 2022
• Study Start: March 15, 2022
• Primary Completion: May 30, 2024
• Study Completion: November 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); ES (2); PL (1)