---
title: 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
overall_status: TERMINATED
phase: PHASE1
sponsor: Gilead Sciences
study_type: INTERVENTIONAL
primary_condition: Non-hodgkin Lymphoma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04502706.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04502706"
ct_last_update_post_date: 2023-06-05
last_seen_at: "2026-05-12T07:28:09.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma

**Official Title:** A Phase 1 Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

**NCT ID:** [NCT04502706](https://clinicaltrials.gov/study/NCT04502706)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Sponsor's decision to discontinue development of this molecule
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** Gilead Sciences
- **Conditions:** Non-hodgkin Lymphoma
- **Start Date:** 2020-11-17
- **Completion Date:** 2022-03-31
- **CT.gov Last Update:** 2023-06-05

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

## 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 Schedule Evaluation (ASE) part and 5) a diffuse large B-cell lymphoma (DLBCL) Expansion part.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Key Inclusion Criteria:

* 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 Criteria:

* 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.
```

## Arms

- **GS-0189 (Monotherapy Dose Escalation, MDE)** (EXPERIMENTAL) — 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 + Rituximab (Combination Dose Escalation, CDE)** (EXPERIMENTAL) — 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 + Rituximab (Pharmacokinetic (PK) Evaluation)** (EXPERIMENTAL) — 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 + Rituximab (Alternate Schedule Evaluation, ASE)** (EXPERIMENTAL) — 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 + Rituximab (DLBCL Expansion)** (EXPERIMENTAL) — 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.

## Interventions

- **GS-0189** (DRUG) — GS-0189 will be administered intravenously.
- **Rituximab** (DRUG) — Rituximab will be administered intravenously.

## Primary Outcomes

- **Percentage of Participants Experiencing Treatment-Emergent Adverse Events** _(time frame: Up to 11 months)_ — Adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

## Secondary Outcomes

- **Percentage of Participants Experiencing Laboratory Abnormalities** _(time frame: Up to 11 months)_
- **Pharmacokinetic (PK) Parameter: AUClast of GS-0189** _(time frame: Up to 11 months)_
- **PK Parameter: AUCtau of GS-0189** _(time frame: Up to 11 months)_
- **PK Parameter: Cmax of GS-0189** _(time frame: Up to 11 months)_
- **PK Parameter: Accumulation Ratio (AR) of GS-0189** _(time frame: Up to 11 months)_
- **PK Parameter: Tmax of GS-0189** _(time frame: Up to 11 months)_
- **PK Parameter: AUC0-tau/D Dose-normalized AUCtau of GS-0189** _(time frame: Up to 11 months)_
- **Percentage of Signal Regulatory Protein Alpha (SIRPα) Receptor Occupancy in the Blood** _(time frame: Up to 11 months)_
- **Serum Concentration of GS-0189** _(time frame: Up to 11 months)_
- **Rate of Anti-GS-0189 Antibody Positivity** _(time frame: Up to 11 months)_
- **Objective response rate (ORR)** _(time frame: Up to 2 years)_
- **Duration of Response (DOR)** _(time frame: Up to 2 years)_
- **Progression-free Survival (PFS)** _(time frame: Up to 2 years)_
- **Overall Survival (OS)** _(time frame: Up to 2 years)_
- **Time to Progression (TTP)** _(time frame: Up to 2 years)_

## Locations (5)

- 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of alabama comprehensive cancer center|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.city of hope|duarte|california|united states` — added _(2026-05-12)_
- `locations.florida cancer specialists|sarasota|florida|united states` — added _(2026-05-12)_
- `locations.washington university school of medicine|st louis|missouri|united states` — added _(2026-05-12)_
- `locations.university of oklahoma health sciences center|oklahoma city|oklahoma|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04502706.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04502706*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*