InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 2 February 2024

STAR CNS: This phase I/II study is seeking to determine the safety and best dose level of a new drug (GB5121) in people with relapsed or refractory central nervous system lymphomaA 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 summary

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-tumour activity and efficacy of the recommended phase 2 dose of GB5121. GB5121 will be given orally twice per day.

Conditions

This trial is treating patients with primary central nervous system lymphoma, primary vitreoretinal lymphoma, or central nervous system-only involvement of a systemic B-cell lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

STAR CNS

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Scientific 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

Eligibility

Inclusion

  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

  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).

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.