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Non-hodgkin LymphomaPhase 1NCT04502706

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

A Phase 1 study testing GS-0189 and Rituximab in people with Non-hodgkin Lymphoma, run by Gilead Sciences at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-hodgkin Lymphoma
What is being tested?
GS-0189 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
5 sitesUnited States
Study dates
17 Nov 2020to 31 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • City of Hope

    Duarte, California, 91010

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
GS-0189, Rituximab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-0189Drug

    Also called FSI-189

    GS-0189 will be administered intravenously.

  • RituximabDrug

    Rituximab will be administered intravenously.

Study groups in NCT04502706
Study groupRoleWhat they receive
GS-0189 (Monotherapy Dose Escalation, MDE)ExperimentalRelapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) participants will receive GS-0189 doses of 10, 30, or 100 mg every 2 weeks.
Receives: Drug: GS-0189
GS-0189 + Rituximab (Combination Dose Escalation, CDE)ExperimentalR/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.
Receives: Drug: GS-0189; Drug: Rituximab
GS-0189 + Rituximab (Pharmacokinetic (PK) Evaluation)ExperimentalR/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.
Receives: Drug: GS-0189; Drug: Rituximab
GS-0189 + Rituximab (Alternate Schedule Evaluation, ASE)ExperimentalR/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.
Receives: Drug: GS-0189; Drug: Rituximab
GS-0189 + Rituximab (DLBCL Expansion)ExperimentalDiffuse 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.
Receives: Drug: GS-0189; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    Adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

    Measured: Up to 11 months

Secondary outcomes (15)

  1. Percentage of Participants Experiencing Laboratory Abnormalities

    Measured: Up to 11 months

  2. Pharmacokinetic (PK) Parameter: AUClast of GS-0189

    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

    Measured: Up to 11 months

  3. PK Parameter: AUCtau of GS-0189

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

    Measured: Up to 11 months

  4. PK Parameter: Cmax of GS-0189

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Up to 11 months

  5. PK Parameter: Accumulation Ratio (AR) of GS-0189

    AR is defined as ratio based on Cmax and AUCtau after first dose and after multiple doses.

    Measured: Up to 11 months

  6. PK Parameter: Tmax of GS-0189

    Tmax is defined as the time (observed time point) of Cmax.

    Measured: Up to 11 months

  7. PK Parameter: AUC0-tau/D Dose-normalized AUCtau of GS-0189

    AUC0-tau/D is defined dose normalized area under the concentration-time curve from time zero (pre dose time point of the infusion) to the end of the dosing interval.

    Measured: Up to 11 months

  8. Percentage of Signal Regulatory Protein Alpha (SIRPα) Receptor Occupancy in the Blood

    Measured: Up to 11 months

  9. Serum Concentration of GS-0189

    Measured: Up to 11 months

  10. Rate of Anti-GS-0189 Antibody Positivity

    Measured: Up to 11 months

  11. Objective response rate (ORR)

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by Lugano Classification response criteria for lymphomas.

    Measured: Up to 2 years

  12. Duration of Response (DOR)

    DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression.

    Measured: Up to 2 years

  13. Progression-free Survival (PFS)

    PFS is defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause.

    Measured: Up to 2 years

  14. Overall Survival (OS)

    OS is defined as the interval from the first dose date of drug to death from any cause.

    Measured: Up to 2 years

  15. Time to Progression (TTP)

    TTP is defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start17 Nov 2020
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Why it stopped: Sponsor's decision to discontinue development of this molecule

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502706
Sponsor's protocol ID
SRP001
Status last verified
May 2022
First submitted
16 Jul 2020
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GS-0189 and Rituximab in people with Non-hodgkin Lymphoma, run by Gilead Sciences at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor's decision to discontinue development of this molecule). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (time frame: Up to 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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