GB5121 in Adult Subjects With Relapsed/Refractory CNS Lymphoma

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Subjects must have histologically/cytologically confirmed primary central nervous system lymphoma (PCNSL), primary vitreoretinal lymphoma (PVRL), or CNS-only systemic High Grade B-cell lymphoma (DLBCL/SCNSL).

2. All subjects must have relapsed/refractory disease and have received at least one prior CNS-directed therapy.

3. Subjects must be able to tolerate gadolinium-enhanced magnetic resonance imaging (MRI) scans, or contrast-enhanced computed tomography (CT).

4. Subjects with parenchymal lesions must have baseline imaging (gadolinium-enhanced MRI or if contraindicated, measurable CT, of the brain) within 28 days prior to first study drug dose. For subjects with leptomeningeal disease only, cerebrospinal fluid (CSF) cytology must document lymphoma cells and/or imaging findings consistent with CSF disease after informed consent and prior to first study dose (at the discretion of the Investigator).

5. Subjects with parenchymal lesions must have measurable disease on imaging (gadolinium-enhanced MRI or if contraindicated, measurable CT, of the brain) prior to first study dose.

6. Subjects 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. Subject 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. Subject is concurrently using other approved or investigational antineoplastic agents.

2. Subject has an active concurrent malignancy requiring active therapy.

3. Subject is allergic to components of the study drug.

4. Subject has a known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.

5. Subject has 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.

6. Subjects with 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.

7. Subject is known to have a history of active or chronic infection with hepatitis C virus (HCV), hepatitis B virus (HBV), as determined by serologic tests.

8. Known history of infection with human immunodeficiency virus (HIV).

9. Subject is known to have an uncontrolled active systemic infection.

10. Subject has a history of stroke or intracranial hemorrhage within 6 months prior to enrollment.

11. Subject has 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.

12. Women who are pregnant or nursing (lactating).