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).
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05240131
- Lead Sponsor
- Galecto Biotech AB
- 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).
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab Placebo Part B of the study, GB1211 (200 or 100 mg BID to be selected from part A) in addition to atezolizumab, for 12 weeks Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab Placebo 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 Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab. GB1211 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. Part A - GB1211 200 mg and 100 mg BID in combination with atezolizumab. 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. Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab GB1211 Part B of the study, GB1211 (200 or 100 mg BID to be selected from part A) in addition to atezolizumab, for 12 weeks Part B - GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab 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 Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab 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 Part C - Extension of GB1211 (200 or 100 mg BID) or Placebo in addition to atezolizumab GB1211 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 Measures
Name Time Method PART A - To assess the safety and tolerability of GB1211 in combination with atezolizumab. 3 weeks Incidence and severity of adverse events as reported by investigators.
PART B - To assess the safety and tolerability of GB1211 in combination with atezolizumab compared to atezolizumab and placebo 12 weeks Incidence and severity of adverse events
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. 12 weeks Independent central review of CT, PET/CT or MRI scan according to RECIST 1.1
Part C - To assess the long-term safety and tolerability of GB1211 in combination with atezolizumab compared to atezolizumab alone. 12 - 40 weeks Incidence and severity of adverse events.
- Secondary Outcome Measures
Name Time Method Part A -To determine the recommended dose (200 mg BID or 100 mg BID) of GB1211 in combination with atezolizumab. 3 weeks Incidence and severity of adverse events as reported by investigators.
Part A and B - To assess response rate according to RECIST v1.1 of GB1211 versus placebo in combination with atezolizumab. 12 weeks Independent central review of CT, PET/CT or MRI scan according to RECIST 1.1
To measure the maximum plasma concentration of GB1211 (Cmax) 12 weeks 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
To measure the time of maximum plasma concentration of GB1211 (Tmax) 12 weeks 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
To measure the area under the concentration-time curve of GB1211 (AUC) 12 weeks 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
Part C - To assess response rates for those patients who enter the study with at least Stable Disease as best response. 12 - 40 weeks Independent central review of CT, PET/CT or MRI scan according to RECIST 1.1
Trial Locations
- Locations (5)
CHRU
🇫🇷Tours, France
Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc
🇵🇱Olsztyn, Poland
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, València, Spain
Centre Georges Grancois Leclerc
🇫🇷Dijon, France