Active — Not RecruitingPhase 1/2

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

United States, Australia, Belgium940 participantsStarted 2017-02-21

Plain-language summary

This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant \[ASCT\]) * Measurable disease, defined as 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 * Able to provide a tumor tissue pretreatment biopsy at last relapse or during screening from a safely accessible site, per investigator determination, providing the patient has more than one measurable target lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of \>/=12 weeks * AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to (\</=) 1 * Adequate liver, hematological and renal function * Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection * Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) * Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potenti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: From Baseline up to 4 weeks

Part I, II and III: Percentage of Participants With Adverse Events (AEs)

Timeframe: From Baseline up to 90 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)

Part II: MTD or OBD of Glofitamab

Timeframe: From Baseline up to 4 weeks

Part II: Recommended Phase II Dose (RP2D) of Glofitamab

Timeframe: From Baseline up to 5 years

Part III: Complete Response (CR) Rate as Assessed by Independent Review Committee (IRC) According to Standard Non-hodgkin's Lymphoma (NHL) Response Criteria (Lugano Classification)

Timeframe: From treatment start up to 5 years

Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab

Timeframe: At pre-defined intervals from Cycle 1 Day 1 to Day 71

Trial details

NCT IDNCT03075696

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03-30

View on ClinicalTrials.gov More Non-Hodgkin's Lymphoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: From Baseline up to 4 weeks

Part I, II and III: Percentage of Participants With Adverse Events (AEs)

Timeframe: From Baseline up to 90 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)

Part II: MTD or OBD of Glofitamab

Timeframe: From Baseline up to 4 weeks

Part II: Recommended Phase II Dose (RP2D) of Glofitamab

Timeframe: From Baseline up to 5 years

Part III: Complete Response (CR) Rate as Assessed by Independent Review Committee (IRC) According to Standard Non-hodgkin's Lymphoma (NHL) Response Criteria (Lugano Classification)

Timeframe: From treatment start up to 5 years

Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab

Timeframe: At pre-defined intervals from Cycle 1 Day 1 to Day 71