Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma
NCT ID: NCT04502706
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2020-11-17
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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GS-0189 (Monotherapy Dose Escalation, MDE)
Relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) participants will receive GS-0189 doses of 10, 30, or 100 mg every 2 weeks.
GS-0189
GS-0189 will be administered intravenously.
GS-0189 + Rituximab (Combination Dose Escalation, CDE)
R/R NHL participants will receive GS-0189 doses of 100, 300, 1000, 2000, and 3000 mg in combination with rituximab at 375 mg/m\^2.
GS-0189
GS-0189 will be administered intravenously.
Rituximab
Rituximab will be administered intravenously.
GS-0189 + Rituximab (Pharmacokinetic (PK) Evaluation)
R/R NHL participants will receive GS-0189 dose of up to 30 mg followed by the highest designated safe dose from the Combination Dose Escalation cohort (CDE) in combination with rituximab at 375 mg/m\^2.
GS-0189
GS-0189 will be administered intravenously.
Rituximab
Rituximab will be administered intravenously.
GS-0189 + Rituximab (Alternate Schedule Evaluation, ASE)
R/R NHL participants will receive GS-0189 every 4 weeks in combination with rituximab 375 mg/m\^2. The GS-0189 dose will be determined based on the totality of safety, PK, and pharmacodynamic (PD) data from the preceding cohorts.
GS-0189
GS-0189 will be administered intravenously.
Rituximab
Rituximab will be administered intravenously.
GS-0189 + Rituximab (DLBCL Expansion)
Diffuse large B-cell lymphoma (DLBCL) participants will receive GS-0189 in combination with rituximab 375 mg/m\^2. The GS-0189 dose will be determined based on the totality of safety, PK, and PD data from the preceding cohorts.
GS-0189
GS-0189 will be administered intravenously.
Rituximab
Rituximab will be administered intravenously.
Interventions
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GS-0189
GS-0189 will be administered intravenously.
Rituximab
Rituximab will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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SRP001
Identifier Type: -
Identifier Source: org_study_id
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