GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma

NCT05242146 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: GB5121-2101
• Study Type: interventional
• Target: 12
• Locations: 6 countries
• Sites: 16

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.

Conditions

CNS Lymphoma

Keywords

R/R PCNSL; SCNSL; PVRL

Outcome Measures

Primary Outcomes (7)

• Phase 1b Dose Escalation - Incidence of Adverse Events

  From first dose until 28 days after the last dose of GB5121

• Phase 1b Dose Escalation - Dose Limiting Toxicity(ies)

  From Cycle 1, Day 1 through Cycle 1, Day 28 inclusive, Each Cycle=28 days

• Phase 1b Dose Escalation - Serious Adverse Events

  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

  From first dose up to approximately 36 months

• Phase 1b Dose Expansion - Incidence of Adverse Events

  From first dose until 28 days after the last dose of GB5121

• Phase 1b Dose Expansion - Serious Adverse Events

  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)

  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

  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

  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

  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

  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

  From Study Day 1 until disease progression assessed by the Investigator per IPCG criteria, unacceptable toxicity, or discontinuation, up to approximately 36 months

Study Arms (1)

GB5121

EXPERIMENTAL

GB5121 orally twice per day (BID)

Drug: GB5121

Interventions

GB5121 DRUG

Capsule containing GB5121

GB5121

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (16)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center Main Campus

New York, New York, 10065, United States

Location

Peter MacCallum Cancer Center

Melbourne, Victoria, 3000, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

South Lyon Hospital Center

Pierre-Bénite, Lyon, 69495, France

Location

Bergonie Institute

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

CHU APHM la Timone / Aix Marseille University

Marseille, Provence-Alpes-Cote d'Azure, 13385, France

Location

La Pitie-Salpetriere University Hospital

Paris, Île-de-France Region, 75013, France

Location

Institut Curie Site Saint-Cloud

Saint-Cloud, Île-de-France Region, 92210, France

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5266202, Israel

Location

Middlemore Hospital

Papatoetoe, Auckland, 2025, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 16, 2022
• Study Start: May 24, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); US (4); CA (1); AU (2); FR (5); NZ (1)