Phase
Condition
Biliary Tract Cancer
Carcinoma
Liver Cancer
Treatment
Tocilizumab
RO7119929
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed diagnosis of one of the following: unresectable advanced ormetastatic HCC (including fibrolamellar HCC) not amenable to a curative treatmentapproach, unresectable advanced or metastatic intrahepatic or perihilar (Klatskin)BTC not amenable to a curative treatment approach, extrahepatic BTC or gallbladdercancer infiltrating the liver or metastasized into the liver with predominant liverdisease, not amenable to a curative treatment approach, metastasized colorectalcancer (CRC), pancreatic ductal adenocarcinoma (PDAC), Gastric cancer (GC), renalcell carcinoma (RCC), triple negative breast cancer (TNBC), cutaneous melanoma, orocular melanoma with predominant liver disease not amenable to a curative treatmentapproach. Participants with other solid tumors with predominant liver disease notamenable to a curative treatment approach might be enrolled after Sponsor approval
Measurable disease with at least one measurable locally untreated liver lesion, asdefined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic and major organ functions
Participants for which there is no available standard therapy likely to conferclinical benefit, or participants who are not candidates for such available therapy
Life expectancy of ≥12 weeks, approximated with Royal Marsden Hospital score 0-1 orGustave Roussy Immune (GRIm) score 0-1. Participants with a Royal Marsden Hospitalor GRIm score of ≥2 and a life expectancy of ≥12 weeks according to theinvestigator's clinical judgement may be enrolled after Medical Monitor approval hasbeen obtained.
For participants with HCC: Child-Pugh score of A6 or better
Exclusion
Exclusion Criteria:
History or clinical evidence of central nervous system (CNS) primary tumors ormetastases including leptomeningeal metastases, unless they have been previouslytreated, are asymptomatic, and have had no requirement for steroids orenzyme-inducing anticonvulsants in the last 14 days prior to Screening
Evidence of any extra-hepatic primary tumor or metastasis requiring prompt medicalintervention
Receipt of prior therapy with a TLR7/8/9 agonist and/or IFN-alpha
Prior chemotherapy, antibody, or other registered or experimental cancer treatmentwithin 3 weeks of study Cycle 1 Day 1. Specifically, no CPI antibody is allowed tobe administered within 6 weeks of study Cycle 1 Day 1
Receipt of investigational agent for any other indication within 3 weeks of dosing
Treatment with systemic immunosuppressive medication (including, but not limited to,corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, andanti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, oranticipation of need for systemic immunosuppressive medication during studytreatment
Local therapy to liver (e.g. radiofrequency ablation, percutaneuous ethanol oracetic acid injection, cryoablation, high-intensity focused ultrasound,transarterial chemoembolization, and transarterial embolization) within 3 weeksprior to initiation of study treatment, radioembolization within 3 months prior toinitiation of study treatment, or non-recovery from side effects of such procedure
Treatment-related toxicities from prior cancer therapy that have not resolved to </=Grade 1 CTC AE prior to study treatment with the exception of the following Grade 2toxicities:
alopecia, peripheral neuropathy, any laboratory changes that still lie within the inclusion criteria defined above
History of other malignancy within 2 years; exception for ductal carcinoma in situnot requiring chemotherapy, low grade cervical intraepithelial neoplasia (CIN),nonmelanoma skin cancer, low grade localized prostate cancer (Gleason score < Grade 7), or optimally treated Stage 1 uterine cancer.
Active or history of immunologic-mediated disease, including but not limited tomyasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease,antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome orGuillain-Barré syndrome
Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, orother infection.
Ascites, pleural effusion, or pericardial effusion requiring medical interventionwithin 12 months prior to study entry.
History of human immunodeficiency virus (HIV) infection
Active hepatitis B virus (HBV) infection
Coinfection of HBV and hepatitis C virus (HCV).
Study Design
Connect with a study center
BC Cancer Agency Vancouver Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Rigshospitalet; Onkologisk Klinik
København Ø, 2100
DenmarkSite Not Available
Queen Mary Hospital; Dept of Medicine
Hong Kong,
Hong KongSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Clínica Universidad de Navarra
Pamplona, Navarra 31620
SpainSite Not Available
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, 08035
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
SpainSite Not Available
Hospital Clínico Universitario de Valencia; Medical Oncology
Valencia, 46010
SpainSite Not Available
Tri-Service General Hospital
Taipei, 11490
TaiwanSite Not Available
National Taiwan Uni Hospital
Taipei City, 10041
TaiwanSite Not Available
City of Hope Cancer Center
Duarte, California 91010
United StatesSite Not Available
Keck School of Medicine - University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20007
United StatesSite Not Available

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