A Dose Escalation Study of 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

Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:February 21, 2017
End Date:March 12, 2021
Contact:Reference Study ID Number: NP30179 www.roche.com/about_roche/roche_worldwide.htm
Phone:888-662-6728 (U.S. and Canada)

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A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Doses of RO7082859 as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This is a Phase I, multicenter, open-label, dose-escalation study designed to evaluate the
efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB),
RO7082859, administered by intravenous (IV) infusion as a single agent and in combination
with obinutuzumab, following the pre-treatment with a one-time, fixed dose of obinutuzumab.
This entry-to-human 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 RO7082859.

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 [SCT])

- Participant must have at least one measureable target lesion (>/=1.5 centimeters [cm])
in its largest dimension by computerized tomography [CT] scan)

- 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
- 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

Exclusion Criteria:

- Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and
lymphoplasmacytic lymphoma

- Participants with acute bacterial, viral, or fungal infection at baseline, confirmed
by a positive blood culture within 72 hours prior to obinutuzumab infusion or by
clinical judgment in the absence of a positive blood culture

- Participants with known active infection, or reactivation of a latent infection,
whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major
episode of infection requiring hospitalization or treatment with IV antibiotics within
4 weeks of dosing

- Prior treatment with systemic immunotherapeutic agents, including, but not limited to,
radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal
antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA4],
anti-programmed death 1 [anti-PD1] and anti-programmed death ligand 1 [anti-PDL1])
within 4 weeks or five half-lives of the drug, whichever is shorter, before
obinutuzumab infusion on Cycle 1 Day -7

- History of treatment-emergent immune-related AEs associated with prior
immunotherapeutic agents

- Documented refractoriness to an obinutuzumab-containing regimen

- Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with
any other investigational anti-cancer agent within 4 weeks prior to obinutuzumab

- Prior solid organ transplantation

- Prior allogeneic SCT

- Autologous SCT within 100 days prior to obinutuzumab infusion

- Participant with history of confirmed progressive multifocal leukoencephalopathy (PML)

- Current or past history of central nervous system (CNS) lymphoma

- 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

- Participants with another invasive malignancy in the last 2 years (with the exception
of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood
for recurrence)

- Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab
infusion or anticipation that such a live attenuated vaccine will be required during
the study

- Received systemic immunosuppressive medications (including but not limited to
cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis
factor agents) with the exception of corticosteroid treatment or equivalent within 2 weeks prior to obinutuzumab infusion

- 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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