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
Status: | Recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/15/2019 |
Start Date: | February 21, 2017 |
End Date: | March 12, 2021 |
Contact: | Reference Study ID Number: NP30179 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
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.
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
(=) 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)
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
infusion
- 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 =25 mg/day prednisone
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
We found this trial at
7
sites
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
Click here to add this to my saved trials
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials