An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    200
  • sponsor
    Hoffmann-La Roche
Updated on 18 October 2022

Summary

This is a first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).

Details
Condition Lymphoma, Non-Hodgkin
Treatment Tocilizumab, Obinutuzumab, Glofitamab, RO7443904
Clinical Study IdentifierNCT05219513
SponsorHoffmann-La Roche
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Body weight >=40 kg
Histologically confirmed hematological malignancy that is expected to express CD19 and CD20 and with clinical evidence of treatment need; 2) relapse after or failure to respond to at least two prior treatment regimens; and 3) no other available treatment options that are known to provide clinical benefit
Must have at least one measurable target lesion (>=1.5 cm) in its largest dimension by computed tomography (CT) scan
Able and willing to provide a fresh tumor biopsy from a safely accessible site, per Investigator's determination
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of >=12 weeks
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 HIV
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1) Women of non-childbearing potential 2) Women of childbearing potential (WOCBP), who, agree to remain abstinent (refrain from heterosexual intercourse) or use of one highly effective contraceptive method during the treatment period and for at least 18 months after obinutuzumab or 5 months after the final dose of RO7443904, 2 months after final dose of glofitamab or 3 months after the final dose of tocilizumab
Male participants must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method with a partner who is a WOCBP during the treatment period and for at least 3 months after obinutuzumab, 5 months after the final dose of RO7443904, 2 months after the final dose of glofitamab or 2 months after the final dose of tocilizumab, whichever is longer

Exclusion Criteria

Circulating lymphoma cells, defined by out-of-range (high) absolute lymphocyte count (ALC) or the presence of abnormal cells in the peripheral blood signifying circulating lymphoma cells
Participants with acute bacterial, viral, or fungal infection at screening
Participants with known active infection or reactivation of a latent infection
Pregnant, breastfeeding, or intending to become pregnant during the study
Prior treatment with systemic immunotherapeutic agents
History of treatment-emergent, immune-related adverse events (AEs) associated with prior immunotherapeutic agents
No persistent AEs from prior anti-cancer therapy Grade >=1
Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational or approved anti-cancer agent
Prior solid organ transplantation
Prior allogeneic stem cell transplant (SCT)
Autologous SCT within 100 days prior to obinutuzumab infusion
Autoimmune disease in active phase or exacerbation/flare within at least 6 months of enrollment
History of immune deficiency disease that increases the risk of infection
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
History of confirmed progressive multifocal leukoencephalopathy
Current or past history of central nervous system (CNS) lymphoma or CNS disease
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Major surgery or significant traumatic injury <28 days prior to the GpT infusion or anticipation of the need for major surgery during study treatment
Participants with another invasive malignancy in the last 2 years
Significant cardiovascular disease
Administration of a live, attenuated vaccine within 4 weeks before GpT infusion or anticipation that such a live attenuated vaccine will be required during the study
Received systemic immunosuppressive medications
History of illicit drug or alcohol abuse within 12 months prior to screening, in the Investigator's judgment
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
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