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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05242146




Registration number
NCT05242146
Ethics application status
Date submitted
31/01/2022
Date registered
16/02/2022
Date last updated
13/06/2023

Titles & IDs
Public title
GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma
Scientific title
A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/ Refractory Primary Central Nervous System Lymphoma
Secondary ID [1] 0 0
GB5121-2101
Universal Trial Number (UTN)
Trial acronym
STAR CNS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CNS Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GB5121

Experimental: GB5121 - GB5121 orally twice per day (BID)


Treatment: Drugs: GB5121
Capsule containing GB5121
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b Dose Escalation - Incidence of Adverse Events
Timepoint [1] 0 0
From first dose until 28 days after the last dose of GB5121
Primary outcome [2] 0 0
Phase 1b Dose Escalation - Dose Limiting Toxicity(ies)
Timepoint [2] 0 0
From Cycle 1, Day 1 through Cycle 1, Day 28 inclusive, Each Cycle=28 days
Primary outcome [3] 0 0
Phase 1b Dose Escalation - Serious Adverse Events
Timepoint [3] 0 0
From consent until 28 days after the last dose of GB5121
Primary outcome [4] 0 0
Phase 1b Dose Escalation - Optimal Biologic Dose and/or Maximum Tolerated Dose and Recommended Phase 2 Dose
Timepoint [4] 0 0
From first dose up to approximately 36 months
Primary outcome [5] 0 0
Phase 1b Dose Expansion - Incidence of Adverse Events
Timepoint [5] 0 0
From first dose until 28 days after the last dose of GB5121
Primary outcome [6] 0 0
Phase 1b Dose Expansion - Serious Adverse Events
Timepoint [6] 0 0
From consent until 28 days after the last dose of GB5121
Primary outcome [7] 0 0
Phase 2 - Objective Response Rate According to International Primary CNS Lymphoma Collaborative Group (IPCG) Criteria by Blinded Independent Central Review Committee (BICR)
Timepoint [7] 0 0
From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcome [1] 0 0
Phase 1b Dose Expansion - Objective Response Rate According to IPCG Criteria by Investigator Assessment
Timepoint [1] 0 0
From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcome [2] 0 0
Phase 2 - Duration of Response by BICR Committee
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Phase 2 - Confirmed Complete Response by BICR Committee
Timepoint [3] 0 0
From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcome [4] 0 0
Phase 2 - Objective Response Rate According to the IPCG Criteria by Investigator Assessment
Timepoint [4] 0 0
From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcome [5] 0 0
Phase 2 - Median Progression-Free Survival
Timepoint [5] 0 0
From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcome [6] 0 0
Phase 2 - Progression-Free Survival at Week 24
Timepoint [6] 0 0
From Study Day 1 until Week 24
Secondary outcome [7] 0 0
Phase 2 - Median Overall Survival
Timepoint [7] 0 0
From Study Day 1 until death, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcome [8] 0 0
Phase 2 - Incidence of Adverse Events
Timepoint [8] 0 0
From first dose until 28 days after the last dose of GB5121
Secondary outcome [9] 0 0
Phase 2 - Incidence of Serious Adverse Events
Timepoint [9] 0 0
From consent until 28 days after the last dose of GB5121

Eligibility
Key inclusion criteria
1. Patients must have histologically/cytologically confirmed primary central nervous system lymphoma (PCNSL), primary vitreoretinal lymphoma (PVRL), or CNS-only involvement of a systemic B-cell lymphoma.
2. All patients must have relapsed/refractory disease and must have received all possible standard-of-care CNS-directed therapy treatment regimens or patients for which further standard-of-care treatment options are contraindicated or declined.
3. Patients must be able to tolerate gadolinium-enhanced magnetic resonance imaging (MRI) scans, or contrast-enhanced computed tomography (CT).
4. Patients with parenchymal lesions must have baseline imaging (gadolinium-enhanced MRI or if contraindicated, contrast-enhanced CT, of the brain) within 28 days prior to first study drug dose. For patients with leptomeningeal disease only, cerebrospinal fluid (CSF) cytology must document lymphoma cells and/or imaging findings consistent with leptomeningeal disease after informed consent and prior to first study dose (at the discretion of the Investigator).
5. Patients with parenchymal lesions must have measurable disease (disease that has at least one lesion on imaging = 10 mm in the longest diameter) on imaging (gadolinium-enhanced MRI or if contraindicated, contrast-enhanced CT, of the brain) prior to first study dose.
6. Patients must be able to tolerate and consent for a lumbar puncture and/or have pre-existing placement of an Ommaya reservoir, unless clinically contraindicated.
7. Patients must have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
8. Demonstrate adequate bone marrow and organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients are concurrently using other approved or investigational antineoplastic agents.
2. Patients have an active concurrent malignancy requiring active therapy.
3. Patients are allergic to components of the study drug.
4. Patients have a known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.
5. Patients who require therapeutic anticoagulation, including dual antiplatelet agents. Patients who have received therapeutic anticoagulation, including dual antiplatelet agents, within 5 half-lives of the anticoagulant or 14 days, whichever is longer, prior to starting the study drug. Patients who require the use of antiplatelet agents should be discussed with the Sponsor's Medical Monitor.
6. Patients have significant abnormalities on screening electrocardiogram (ECG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
7. Patients with any of the following will be excluded:

1. A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval > 480 ms [CTCAE grade 2]) using Frederica's QT correction formula.
2. A history of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
3. The use of concomitant medications that prolong the QT/QTc interval.
8. Patients are known to have a history of active or chronic infection with hepatitis C virus (HCV), hepatitis B virus (HBV), as determined by serologic tests.
9. Known history of infection with human immunodeficiency virus (HIV).
10. Patients are known to have an uncontrolled active infection.
11. Patients have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment.
12. Patients have a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the Investigator, could compromise the subject's safety or put the study outcomes at undue risk.
13. Women who are pregnant or nursing (lactating).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/05/2023
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
France
State/province [6] 0 0
Ile-de-France
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Nouvelle-Aquitaine
Country [9] 0 0
France
State/province [9] 0 0
Provence-Alpes-Cote d'Azure
Country [10] 0 0
France
State/province [10] 0 0
Île-de-France
Country [11] 0 0
Israel
State/province [11] 0 0
Haifa
Country [12] 0 0
Israel
State/province [12] 0 0
Jerusalem
Country [13] 0 0
Israel
State/province [13] 0 0
Ramat Gan
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05242146
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05242146