Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Gilead Sciences
Study ID
NCT04502706
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GS-0189 — DRUG
    GS-0189 will be administered intravenously.
  • Rituximab — DRUG
    Rituximab will be administered intravenously.

Study Details

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 (R/R) non-Hodgkin lymphoma (NHL).

Key Dates

First listed
Aug 6, 2020
Start date
Nov 17, 2020
Status verified
May 2022
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 11 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama Comprehensive Cancer CenterBirminghamAlabama35233-
City of HopeDuarteCalifornia91010-
Florida Cancer SpecialistsSarasotaFlorida34232-
Washington University School of MedicineSt LouisMissouri63110-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-

Find similar trials in Birmingham, AL

By research site
University of Alabama Comprehensive Cancer Center· Birmingham, ALCity of Hope· Duarte, CAFlorida Cancer Specialists· Sarasota, FLWashington University School of Medicine· St Louis, MOUniversity of Oklahoma Health Sciences Center· Oklahoma City, OK

Related Studies