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Non-Small Cell Lung CancerPhase 1/2NCT05240131

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).

A Phase 1/2 study testing GB1211 and Atezolizumab in people with Non-Small Cell Lung Cancer, run by Galecto Biotech AB at 5 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
GB1211 and Atezolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
5 sitesin 3 countries
Study dates
15 Mar 2022to 1 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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 x 109/L (1500/µL) without granulocyte colony-stimulating factor support.
  • Lymphocyte count ≥0.5 x 109/L (500/µL).
  • Platelet count ≥ 100 x 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 x upper limit of normal (ULN), with the following exceptions:
  • Patients with documented liver metastases: AST and ALT ≤ 5 x ULN.
  • Patients with documented liver or bone metastases: ALP ≤ 5 x ULN.
  • Total bilirubin ≤ 1.5 x ULN with the following exception:
  • Patients with known Gilbert disease: total bilirubin ≤ 3 x 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 x ULN.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Patients with severe infection within 4 weeks prior to initiation of study treatment.
  • Patients with acute neurological events (e.g., intracranial or subarachnoid haemorrhage, stroke, intracranial trauma) within 6 months of inclusion.
  • 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.
  • 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).

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

France2 sites

  • Centre Georges Grancois Leclerc

    Dijon, 21000

  • CHRU

    Tours, 37044

Other trials in France

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario y Politécnico La Fe

    Valencia, València, 46026

Other trials in Spain

Poland1 site

  • Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc

    Olsztyn, 10-357

Other trials in Poland

About this study

Official title: 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).

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).

Read the detailed description

The study will be carried out in three parts: The core study is comprised of part A (dose finding and safety) and part B (efficacy and safety). Part C is an extension phase of the core study to collect long-term safety data.

In part A of the study, open-label sentinel dosing will be undertaken to assess safety and tolerability of GB1211 at 200 mg BID and 100 mg BID in combination with atezolizumab including 4 patients in each dose cohort. Patients enrolled in part A may continue treatment with 200 mg GB1211 BID or 100 mg GB1211 BID and atezolizumab for 12 weeks, after which the patients will be offered treatment in the part C study, if they have achieved clinical benefit as best response during the first 12 weeks of treatment (SD or better response according to RECIST 1.1).

In part B of the study, patients will randomised (1:1) for blinded treatment to receive either GB1211 (200 or 100 mg BID to be selected from part A) or placebo, in addition to atezolizumab, for 12 weeks, after which the patients will be offered treatment in part C, if they have achieved clinical benefit as best response during the first 12 weeks of treatment (SD or better response according to RECIST 1.1).

In part C, this treatment will be blinded until part B has been unblinded. After unblinding, patients will continue to receive the same treatment they had received in part B: GB1211 and atezolizumab or atezolizumab only (no placebo) if they experience continued benefit from treatment. The patients will be treated until disease progression or unacceptable toxicity.

After the end of the study treatment all patients will be followed 4 weeks for safety, regardless of the study part in which the last study treatment was given.

Being tested
GB1211, Placebo, Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB1211Drug

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

  • PlaceboDrug

    Placebo is administered orally twice a day.

  • AtezolizumabDrug

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

Study groups in NCT05240131
Study groupRoleWhat they receive
Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab.ExperimentalPart 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.
Receives: Drug: GB1211; Drug: Atezolizumab
Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumabExperimentalPart B of the study, GB1211 (200 or 100 mg BID to be selected from part A) in addition to atezolizumab, for 12 weeks
Receives: Drug: GB1211; Drug: Placebo; Drug: Atezolizumab
Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumabExperimentalExtension 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
Receives: Drug: GB1211; Drug: Placebo; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence and severity of adverse events as reported by investigators.

    Measured: 3 weeks

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

  4. 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.

    Measured: 12 - 40 weeks

Secondary outcomes (6)

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

    Incidence and severity of adverse events as reported by investigators.

    Measured: 3 weeks

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

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

    Measured: 12 weeks

  3. To measure the maximum plasma concentration of GB1211 (Cmax)

    Plasma concentrations of GB1211 [Time Frame: Part A - Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, 12 hours post-dose; Cycle 2 Day 1: pre-dose, 2, 4, 6, 8, 12 hours post-dose; Cycle 3 Day 1: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose; End of Treatment: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose. Part B - Cycle 1 Day 1: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose; End of Treatment: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose] for the calculation of pharmacokinetic parameter maximum plasma concentration (Cmax) of GB1211

    Measured: 12 weeks

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

    Plasma concentrations of GB1211 [Time Frame: Part A - Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, 12 hours post-dose; Cycle 2 Day 1: pre-dose, 2, 4, 6, 8, 12 hours post-dose; Cycle 3 Day 1: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose; End of Treatment: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose. Part B - Cycle 1 Day 1: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose; End of Treatment: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose] for the calculation of pharmacokinetic parameter time of the maximum plasma concentration (Tmax) of GB1211

    Measured: 12 weeks

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

    Plasma concentrations of GB1211 [Time Frame: Part A - Cycle 1 Day 1: pre-dose, 2, 4, 6, 8, 12 hours post-dose; Cycle 2 Day 1: pre-dose, 2, 4, 6, 8, 12 hours post-dose; Cycle 3 Day 1: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose; End of Treatment: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose. Part B - Cycle 1 Day 1: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose; End of Treatment: pre-dose, between 2 and 4 hours post-dose, between 4 and 8 hours post-dose] for the calculation of pharmacokinetic parameter area under the plasma concentration versus time curve (AUC) of GB1211

    Measured: 12 weeks

  6. Part C - To assess response rates for those patients who enter the study with at least Stable Disease as best response.

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

    Measured: 12 - 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start15 Mar 2022
  3. Primary completion30 May 2024 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240131
Sponsor's protocol ID
GALLANT-1
Status last verified
Apr 2024
First submitted
27 Jan 2022
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GB1211 and Atezolizumab in people with Non-Small Cell Lung Cancer, run by Galecto Biotech AB at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART A - To assess the safety and tolerability of GB1211 in combination with atezolizumab. (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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