CNS LymphomaPhase 1STAR CNSNCT05242146
GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma
A Phase 1 study testing GB5121 in people with CNS Lymphoma, run by GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 16 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lymphoma
- What is being tested?
- GB5121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 24 May 2022to 11 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Patients must be able to tolerate gadolinium-enhanced magnetic resonance imaging (MRI) scans, or contrast-enhanced computed tomography (CT).
- 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).
- 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.
- 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.
- Patients must have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate bone marrow and organ function.
Who cannot join
- Patients are concurrently using other approved or investigational antineoplastic agents.
- Patients have an active concurrent malignancy requiring active therapy.
- Patients are allergic to components of the study drug.
- Patients have a known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.
- 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.
- 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.
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- Patients with any of the following will be excluded:
- 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.
- A history of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
- 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.
- Known history of infection with human immunodeficiency virus (HIV).
- Patients are known to have an uncontrolled active infection.
- Patients have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- 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.
- Women who are pregnant or nursing (lactating).
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
France5 sites
Bergonie Institute
Bordeaux, New Aquitaine, 33076
CHU APHM la Timone / Aix Marseille University
Marseille, Provence-Alpes-Cote d'Azure, 13385
La Pitie-Salpetriere University Hospital
Paris, Île-de-France Region, 75013
South Lyon Hospital Center
Pierre-Bénite, Lyon, 69495
Institut Curie Site Saint-Cloud
Saint-Cloud, Île-de-France Region, 92210
United States4 sites
Mayo Clinic
Jacksonville, Florida, 32224
Memorial Sloan Kettering Cancer Center Main Campus
New York, New York, 10065
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Israel3 sites
Rambam Health Care Campus
Haifa, 3109601
Hadassah Medical Center
Jerusalem, 9112001
Chaim Sheba Medical Center
Ramat Gan, 5266202
Australia2 sites
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
Official 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
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.
Read the detailed description
Note: The Phase 1b dose expansion and Phase 2 parts of the study were not initiated.
- Conditions
- CNS Lymphoma
- Being tested
- GB5121
- Keywords
- R/R PCNSL, SCNSL, PVRL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB5121Drug
Capsule containing GB5121
| Study group | Role | What they receive |
|---|---|---|
| GB5121 | Experimental | GB5121 orally twice per day (BID) Receives: Drug: GB5121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b Dose Escalation - Incidence of Adverse Events
Measured: From first dose until 28 days after the last dose of GB5121
Phase 1b Dose Escalation - Dose Limiting Toxicity(ies)
Measured: From Cycle 1, Day 1 through Cycle 1, Day 28 inclusive, Each Cycle=28 days
Phase 1b Dose Escalation - Serious Adverse Events
Measured: 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
Measured: From first dose up to approximately 36 months
Phase 1b Dose Expansion - Incidence of Adverse Events
Measured: From first dose until 28 days after the last dose of GB5121
Phase 1b Dose Expansion - Serious Adverse Events
Measured: 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)
Measured: From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months
Secondary outcomes (9)
Phase 1b Dose Expansion - Objective Response Rate According to IPCG Criteria by Investigator Assessment
Measured: 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 - Duration of Response by BICR Committee
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Study Day 1 until Week 24
Phase 2 - Median Overall Survival
Measured: From Study Day 1 until death, unacceptable toxicity, or discontinuation, up to approximately 36 months
Phase 2 - Incidence of Adverse Events
Measured: From first dose until 28 days after the last dose of GB5121
Phase 2 - Incidence of Serious Adverse Events
Measured: From consent until 28 days after the last dose of GB5121
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start24 May 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242146
- Sponsor's protocol ID
- GB5121-2101
- Acronym
- STAR CNS
- Status last verified
- Jun 2023
- First submitted
- 31 Jan 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05242146
- Acronym / sponsor ID
- STAR CNS / GB5121-2101
- Conditions
- CNS Lymphoma
- Keywords
- R/R PCNSL, SCNSL, PVRL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Note: The Phase 1b dose expansion and Phase 2 parts of the study were not initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB5121 | Experimental | Drug: GB5121GB5121 orally twice per day (BID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
- Patients must be able to tolerate gadolinium-enhanced magnetic resonance imaging (MRI) scans, or contrast-enhanced computed tomography (CT).
- 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).
- 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.
Key exclusion criteria (16 listed)
- Patients are concurrently using other approved or investigational antineoplastic agents.
- Patients have an active concurrent malignancy requiring active therapy.
- Patients are allergic to components of the study drug.
- Patients have a known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB5121Capsule containing GB5121 | Drug | GB5121 |
Primary outcome
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
9 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB5121 in people with CNS Lymphoma, run by GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, United States, Israel, Australia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b Dose Escalation - Incidence of Adverse Events (time frame: From first dose until 28 days after the last dose of GB5121). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.