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GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma (STAR CNS)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05242146
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. )

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.

Condition or disease Intervention/treatment Phase
CNS Lymphoma Drug: GB5121 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: GB5121
GB5121 orally twice per day (BID)
Drug: GB5121
Capsule containing GB5121




Primary Outcome Measures :
  1. Phase 1b Dose Escalation - Incidence of Adverse Events [ Time Frame: From first dose until 28 days after the last dose of GB5121 ]
  2. 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 ]
  3. Phase 1b Dose Escalation - Serious Adverse Events [ Time Frame: From consent until 28 days after the last dose of GB5121 ]
  4. 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 ]
  5. Phase 1b Dose Expansion - Incidence of Adverse Events [ Time Frame: From first dose until 28 days after the last dose of GB5121 ]
  6. Phase 1b Dose Expansion - Serious Adverse Events [ Time Frame: From consent until 28 days after the last dose of GB5121 ]
  7. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Phase 2 - Progression-Free Survival at Week 24 [ Time Frame: From Study Day 1 until Week 24 ]
  7. Phase 2 - Median Overall Survival [ Time Frame: From Study Day 1 until death, unacceptable toxicity, or discontinuation, up to approximately 36 months ]
  8. Phase 2 - Incidence of Adverse Events [ Time Frame: From first dose until 28 days after the last dose of GB5121 ]
  9. Phase 2 - Incidence of Serious Adverse Events [ Time Frame: From consent until 28 days after the last dose of GB5121 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05242146


Contacts
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Contact: GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. 1-866-668-4083 ClinicalTrials@gossamerbio.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center Main Campus Recruiting
New York, New York, United States, 10065
Australia, Victoria
Peter MacCallum Cancer Center Recruiting
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
France
Institut Curie Site Saint-Cloud Recruiting
Saint-Cloud, Ile-de-France, France, 92210
South Lyon Hospital Center Recruiting
Pierre-Bénite, Lyon, France, 69495
Bergonie Institute Recruiting
Bordeaux, Nouvelle-Aquitaine, France, 33076
CHU APHM la Timone / Aix Marseille University Recruiting
Marseille, Provence-Alpes-Cote d'Azure, France, 13385
La Pitie-Salpetriere University Hospital Recruiting
Paris, Île-de-France, France, 75013
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Hadassah Medical Center Recruiting
Jerusalem, Israel, 9112001
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 5266202
New Zealand
Middlemore Hospital Recruiting
Papatoetoe, Auckland, New Zealand, 2025
Sponsors and Collaborators
GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Investigators
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Study Director: Renee Ward, MD, PhD GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
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Responsible Party: GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT05242146    
Other Study ID Numbers: GB5121-2101
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gossamer Bio Inc. ( GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. ):
R/R PCNSL
SCNSL
PVRL
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases