GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma

CNS Lymphoma Clinical Trial

— STAR CNS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05242146
• Other study ID #: GB5121-2101
• Status: Terminated
• Phase: Phase 1
• Start date: May 24, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: June 2023
• Source: Gossamer Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the recommended phase 2 dose of GB5121.

Description:

Note: The Phase 1b dose expansion and Phase 2 parts of the study were not initiated.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• CNS Lymphoma
• Lymphoma

Intervention

Drug:
• GB5121
Capsule containing GB5121

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Center	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Canada	The Ottawa Hospital	Ottawa	Ontario
France	Bergonie Institute	Bordeaux	Nouvelle-Aquitaine
France	CHU APHM la Timone / Aix Marseille University	Marseille	Provence-Alpes-Cote d'Azure
France	La Pitie-Salpetriere University Hospital	Paris	Île-de-France
France	South Lyon Hospital Center	Pierre-Bénite	Lyon
France	Institut Curie Site Saint-Cloud	Saint-Cloud	Ile-de-France
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Chaim Sheba Medical Center	Ramat Gan
New Zealand	Middlemore Hospital	Papatoetoe	Auckland
United States	Mayo Clinic	Jacksonville	Florida
United States	Memorial Sloan Kettering Cancer Center Main Campus	New York	New York
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Israel,  New Zealand, 

Outcome

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