Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
GB5121-2101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
STAR CNS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
CNS Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - GB5121
Experimental: GB5121 - GB5121 orally twice per day (BID)
Treatment: Drugs: GB5121
Capsule containing GB5121
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase 1b Dose Escalation - Incidence of Adverse Events
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From first dose until 28 days after the last dose of GB5121
Query!
Primary outcome [2]
0
0
Phase 1b Dose Escalation - Dose Limiting Toxicity(ies)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
From Cycle 1, Day 1 through Cycle 1, Day 28 inclusive, Each Cycle=28 days
Query!
Primary outcome [3]
0
0
Phase 1b Dose Escalation - Serious Adverse Events
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From consent until 28 days after the last dose of GB5121
Query!
Primary outcome [4]
0
0
Phase 1b Dose Escalation - Optimal Biologic Dose and/or Maximum Tolerated Dose and Recommended Phase 2 Dose
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
From first dose up to approximately 36 months
Query!
Primary outcome [5]
0
0
Phase 1b Dose Expansion - Incidence of Adverse Events
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
From first dose until 28 days after the last dose of GB5121
Query!
Primary outcome [6]
0
0
Phase 1b Dose Expansion - Serious Adverse Events
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
From consent until 28 days after the last dose of GB5121
Query!
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)
Query!
Assessment method [7]
0
0
Query!
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
Query!
Secondary outcome [1]
0
0
Phase 1b Dose Expansion - Objective Response Rate According to IPCG Criteria by Investigator Assessment
Query!
Assessment method [1]
0
0
Query!
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
Query!
Secondary outcome [2]
0
0
Phase 2 - Duration of Response by BICR Committee
Query!
Assessment method [2]
0
0
Query!
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
Query!
Secondary outcome [3]
0
0
Phase 2 - Confirmed Complete Response by BICR Committee
Query!
Assessment method [3]
0
0
Query!
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
Query!
Secondary outcome [4]
0
0
Phase 2 - Objective Response Rate According to the IPCG Criteria by Investigator Assessment
Query!
Assessment method [4]
0
0
Query!
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
Query!
Secondary outcome [5]
0
0
Phase 2 - Median Progression-Free Survival
Query!
Assessment method [5]
0
0
Query!
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
Query!
Secondary outcome [6]
0
0
Phase 2 - Progression-Free Survival at Week 24
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
From Study Day 1 until Week 24
Query!
Secondary outcome [7]
0
0
Phase 2 - Median Overall Survival
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
From Study Day 1 until death, unacceptable toxicity, or discontinuation, up to approximately 36 months
Query!
Secondary outcome [8]
0
0
Phase 2 - Incidence of Adverse Events
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
From first dose until 28 days after the last dose of GB5121
Query!
Secondary outcome [9]
0
0
Phase 2 - Incidence of Serious Adverse Events
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
From consent until 28 days after the last dose of GB5121
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/05/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
11/05/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
12
Query!
Recruitment in Australia
Recruitment state(s)
VIC,WA
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Center - Melbourne
Query!
Recruitment hospital [2]
0
0
Linear Clinical Research - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Minnesota
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Ontario
Query!
Country [6]
0
0
France
Query!
State/province [6]
0
0
Ile-de-France
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Lyon
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Nouvelle-Aquitaine
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Provence-Alpes-Cote d'Azure
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Île-de-France
Query!
Country [11]
0
0
Israel
Query!
State/province [11]
0
0
Haifa
Query!
Country [12]
0
0
Israel
Query!
State/province [12]
0
0
Jerusalem
Query!
Country [13]
0
0
Israel
Query!
State/province [13]
0
0
Ramat Gan
Query!
Country [14]
0
0
New Zealand
Query!
State/province [14]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05242146
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05242146
Download to PDF