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).

Sponsor
Galecto Biotech AB
Study ID
NCT05240131
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GB1211 — DRUG
    GB1211 is a galectin 3 inhibitor an orally available small molecular anti-fibrotic. It is administered orally twice a day.
  • Placebo — DRUG
    Placebo is administered orally twice a day.
  • Atezolizumab — DRUG
    Atezolizumab is an PD-L1 inhibitor administered as an intravenous infusion every three weeks at a dose of 1200mg

Study Details

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).

Key Dates

Start date
Mar 15, 2022
Status verified
Apr 2024
Primary completion
May 30, 2024
Completion
Nov 1, 2025

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab.
    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.
  • Experimental: Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab
    Part B of the study, GB1211 (200 or 100 mg BID to be selected from part A) in addition to atezolizumab, for 12 weeks
  • Experimental: Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab
    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

Primary Outcome Measure

PART A - To assess the safety and tolerability of GB1211 in combination with atezolizumab. [ Time Frame: 3 weeks ]

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