The STAR CNS trial is a 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.
Note: The Phase 1b dose expansion and Phase 2 parts of the study were not initiated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Capsule containing GB5121
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Phase 1b Dose Escalation - Incidence of Adverse Events
Time frame: From first dose until 28 days after the last dose of GB5121
Phase 1b Dose Escalation - Dose Limiting Toxicity(ies)
Time frame: From Cycle 1, Day 1 through Cycle 1, Day 28 inclusive, Each Cycle=28 days
Phase 1b Dose Escalation - Serious Adverse Events
Time frame: From consent until 28 days after the last dose of GB5121
Phase 1b Dose Escalation - Optimal Biologic Dose and/or Maximum Tolerated Dose and Recommended Phase 2 Dose
Time frame: From first dose up to approximately 36 months
Phase 1b Dose Expansion - Incidence of Adverse Events
Time frame: From first dose until 28 days after the last dose of GB5121
Phase 1b Dose Expansion - Serious Adverse Events
Time frame: From consent until 28 days after the last dose of GB5121
Phase 2 - Objective Response Rate According to International Primary CNS Lymphoma Collaborative Group (IPCG) Criteria by Blinded Independent Central Review Committee (BICR)
Time frame: From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 1b Dose Expansion - Objective Response Rate According to IPCG Criteria by Investigator Assessment
Time frame: From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
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Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center Main Campus
New York, New York, United States
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
The Ottawa Hospital
Ottawa, Ontario, Canada
South Lyon Hospital Center
Pierre-Bénite, Lyon, France
Bergonie Institute
Bordeaux, Nouvelle-Aquitaine, France
CHU APHM la Timone / Aix Marseille University
Marseille, Provence-Alpes-Cote d'Azure, France
...and 6 more locations
Phase 2 - Duration of Response by BICR Committee
Time frame: From first observation of complete response, unconfirmed complete response or partial response until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 2 - Confirmed Complete Response by BICR Committee
Time frame: From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 2 - Objective Response Rate According to the IPCG Criteria by Investigator Assessment
Time frame: From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 2 - Median Progression-Free Survival
Time frame: From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 2 - Progression-Free Survival at Week 24
Time frame: From Study Day 1 until Week 24
Phase 2 - Median Overall Survival
Time frame: From Study Day 1 until death, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 2 - Incidence of Adverse Events
Time frame: From first dose until 28 days after the last dose of GB5121
Phase 2 - Incidence of Serious Adverse Events
Time frame: From consent until 28 days after the last dose of GB5121