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LymphomaPhase 1NCT04657302

A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 1 study testing Obinutuzumab, Glofitamab and Tocilizumab in people with Lymphoma, run by Hoffmann-La Roche at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Obinutuzumab, Glofitamab and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesChina
Study dates
8 Jan 2021to 12 Jan 2024
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

  • Histologically-confirmed DLBCL
  • Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (including at least one prior regimen containing anthracycline, and at least one containing an anti-CD20-directed therapy)
  • Participants must have measurable disease: at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension; or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 1 or 1
  • Adverse events from prior anti-cancer therapy must have resolved to Grade </=1
  • Adequate liver, hematological, and renal function
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  • Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol, and agree to refrain from donating eggs during the treatment period and for at least 18 months after the final dose of obinutuzumab, 2 months after the final dose of glofitamab, and 3 months after the final dose of tocilizumab (if applicable)
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol, and agree to refrain from donating sperm during the treatment period and for at least 3 months after the final dose of obinutuzumab, 4 months after the final dose of glofitamab, and 2 months after the final dose of tocilizumab (if applicable)
  • Reside in the People's Republic of China

Who cannot join

  • Richter's transformation
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to first study treatment
  • Suspected or latent tuberculosis
  • Positive for HIV, hepatitis C (HCV), or hepatitis B (HBV)
  • Known or suspected chronic active Epstein-Barr virus infection
  • Known or suspected history of hemaphagocytic lymphohistiocytosis (HLH)
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  • Prior treatment with systemic immunotherapeutic agents
  • History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
  • Documented refractoriness to an obinutuzumab monotherapy-containing regimen
  • Treatment with standard radiotherapy, any chemotherapeutic agent, including CAR T therapy
  • Prior solid organ or allogenic stem cell transplantation
  • Autologous stem cell transplantation within 100 days prior to obinutuzumab infusion
  • Active autoimmune disease requiring treatment
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Current or past history of CNS lymphoma
  • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
  • Major surgery or significant traumatic injury < 28 days prior to obinutuzumab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Another invasive malignancy in the last 2 years
  • Significant cardiovascular disease
  • Administration of a live, attenuated vaccine within 4 weeks before obinutizumab infusion, or anticipation that one will be required during the study
  • Systemic immunosuppresive medications

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

    Guangzhou, 510060

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Province Hospital

    Nanjing, 210008

  • Tianjin Cancer Hospital

    Tianjin, 300060

Other trials in China

About this study

Official title: A Phase I, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Glofitamab as Single Agent Administered After a Fixed, Single Dose Pretreatment of Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Conditions
Lymphoma
Being tested
Obinutuzumab, Glofitamab, Tocilizumab
Medical subject headings
Lymphoma

What participants receive

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

  • ObinutuzumabDrug

    Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.

  • GlofitamabDrug

    Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).

  • TocilizumabDrug

    Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

Study groups in NCT04657302
Study groupRoleWhat they receive
R/R DLBCLExperimentalParticipants will receive a fixed dose of obinutuzumab pre-treatment followed by glofitamab on Cycle 1 Days 8 and 15, then every 3 weeks (Q3W) from Cycles 2-12 (cycle length = 21 days).
Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Tocilizumab

What is being measured

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

  1. Percentage of Participants with Adverse Events (AEs)

    Measured: Up to 3.5 years

  2. Serum Concentration of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  3. Total Exposure (AUC) of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  4. Maximum Serum Concentration (Cmax) of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  5. Minimum Serum Concentration (Cmin) of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  6. Clearance of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  7. Volume of Distribution at Steady State (Vss) of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  8. Half-life (T1/2) of Glofitamab

    Measured: At pre-defined intervals up to 3.5 years

  9. Complete Response Rate (CRR) as Assessed by an Independent Review Committee (IRC)

    Measured: Up to 3.5 years

  10. Percentage of Participants with Anti-Drug Antibodies (ADA)

    Measured: Up to 3.5 years

Secondary outcomes (9)

  1. Investigator-Assessed CRR

    Measured: Up to 3.5 years

  2. Objective Response Rate (ORR) as Assessed by IRC

    Measured: Up to 3.5 years

  3. ORR as Assessed by Investigator

    Measured: Up to 3.5 years

  4. Duration of Objective Response (DOR) as Assessed by IRC and Investigator

    Measured: Up to 3.5 years

  5. Duration of Complete Response (CR) as Assessed by IRC and Investigator

    Measured: Up to 3.5 years

  6. Progression-Free Survival (PFS) as Determined by IRC and Investigator

    Measured: Up to 3.5 years

  7. Overall Survival (OS)

    Measured: Up to 3.5 years

  8. Time to First Overall Response (TFOR) as Assessed by IRC and Investigator

    Measured: Up to 3.5 years

  9. Time to First Complete Response (TFCR) as Assessed by IRC and Investigator

    Measured: Up to 3.5 years

Timeline

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

  1. First posted8 Dec 2020
  2. Study start8 Jan 2021
  3. Primary completion25 Oct 2022
  4. Study completion12 Jan 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657302
Sponsor's protocol ID
YO42610
Status last verified
Jan 2024
First submitted
1 Dec 2020
Last updated
19 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Obinutuzumab, Glofitamab and Tocilizumab in people with Lymphoma, run by Hoffmann-La Roche at 6 sites in China.

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 10 inclusion and 23 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: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 with Adverse Events (AEs) (time frame: Up to 3.5 years). The study lists 10 primary outcomes in all. 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 NCT04657302.

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 19 Jan 2024.

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