TerminatedPhase 1

GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma

Stopped: Sponsor decision

United States, Australia12 participantsStarted 2022-05-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

Phase 1b Dose Escalation - Incidence of Adverse Events

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

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

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

Phase 1b Dose Escalation - Serious Adverse Events

Timeframe: 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

Timeframe: From first dose up to approximately 36 months

Phase 1b Dose Expansion - Incidence of Adverse Events

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

Phase 1b Dose Expansion - Serious Adverse Events

Timeframe: 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)

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

Trial details

NCT IDNCT05242146

SponsorGB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-11

View on ClinicalTrials.gov More CNS Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

Phase 1b Dose Escalation - Incidence of Adverse Events

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

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

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

Phase 1b Dose Escalation - Serious Adverse Events

Timeframe: 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

Timeframe: From first dose up to approximately 36 months

Phase 1b Dose Expansion - Incidence of Adverse Events

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

Phase 1b Dose Expansion - Serious Adverse Events

Timeframe: 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)

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