NCT05242146

GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• CNS Lymphoma

Interventions

Type	Name	Description
DRUG	GB5121	Capsule containing GB5121

Timeline

• Start date: 2022-05-24
• Primary completion: 2023-05-11
• Completion: 2023-05-11
• First posted: 2022-02-16
• Last updated: 2023-06-13

Locations

16 sites across 6 countries: United States, Australia, Canada, France, Israel, New Zealand

Regulatory

• FDA-regulated drug study