Status:
TERMINATED
Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Gilead Sciences
Conditions:
Non-hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to determine the safety and tolerability of GS-0189 (formerly FSI-189) as monotherapy and in combination with rituximab in participants with relapsed/refractory ...
Detailed Description
The study will consist of 5 parts: 1) an initial Monotherapy Dose Escalation (MDE) part, 2) a Combination Dose Escalation (CDE) part, 3) a Pharmacokinetic (PK) Evaluation part, 4) an Alternate Schedul...
Eligibility Criteria
Inclusion
- Key
- DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) relapsed/refractory (R/R) to at least 2 prior lines of therapy. Prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted. Individuals must be at least 3 months out from prior autologous hematopoietic cell transplantation. Individuals with indolent lymphomas must be candidates for systemic treatment in the judgment of the treating physician.
- In the DLBCL Expansion part: DLBCL that is relapsed or refractory to at least 2 prior lines of therapy. Prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted.
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
- For the DLBCL expansion cohort, disease must be measurable for response per Lugano criteria. For all other cohorts, disease must be measurable or assessable for response per Lugano criteria.
- Exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
- Key
Exclusion
- Individuals with active brain metastases (Individuals with stable treated central nervous system (CNS) lesions who are off corticosteroid therapy for at least 3 weeks are not considered active.
- Individuals with Burkitt's lymphoma.
- Prior treatment with a chimeric antigen receptor (CAR) T-cell therapy ≤ 90 days from first dose of study drug.
- Prior allogeneic stem cell transplant.
- Previous anticancer therapy including chemotherapy, hormonal therapy, and investigational agents within 3 weeks or at least 4 half-lives (up to a maximum of 4 weeks), whichever is longer, prior to first dose of study drug.
- Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
- Prior treatment with CD47 or signal regulatory protein alpha (SIRPα)-targeting agents.
- Hypersensitivity to the active substance, to murine proteins, or to any of the other excipients of rituximab
- Significant medical diseases or conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk:benefit ratio of participating in the study.
- Rituximab-containing cohorts only: Receipt of live/attenuated vaccines within 30 days of rituximab dosing
- Has persisting toxicity related to prior therapy of Grade \> 1 in severity per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04502706
Start Date
November 17 2020
End Date
March 31 2022
Last Update
June 5 2023
Active Locations (5)
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1
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
2
City of Hope
Duarte, California, United States, 91010
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110