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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04338685
Other study ID # WP41377
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 16, 2020
Est. completion date January 9, 2023

Study information

Verified date December 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement. The primary objective of the study is to explore the safety and to determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date January 9, 2023
Est. primary completion date January 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed diagnosis of one of the following: unresectable advanced or metastatic HCC (including fibrolamellar HCC) not amenable to a curative treatment approach, unresectable advanced or metastatic intrahepatic or perihilar (Klatskin) BTC not amenable to a curative treatment approach, extrahepatic BTC or gallbladder cancer infiltrating the liver or metastasized into the liver with predominant liver disease, not amenable to a curative treatment approach, metastasized colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), Gastric cancer (GC), renal cell carcinoma (RCC), triple negative breast cancer (TNBC), cutaneous melanoma, or ocular melanoma with predominant liver disease not amenable to a curative treatment approach. Participants with other solid tumors with predominant liver disease not amenable to a curative treatment approach might be enrolled after Sponsor approval - Measurable disease with at least one measurable locally untreated liver lesion, as defined 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 confer clinical benefit, or participants who are not candidates for such available therapy - Life expectancy of =12 weeks, approximated with Royal Marsden Hospital score 0-1 or Gustave Roussy Immune (GRIm) score 0-1. Participants with a Royal Marsden Hospital or GRIm score of =2 and a life expectancy of =12 weeks according to the investigator's clinical judgement may be enrolled after Medical Monitor approval has been obtained. - For participants with HCC: Child-Pugh score of A6 or better Exclusion Criteria: - History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases, unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days prior to Screening - Evidence of any extra-hepatic primary tumor or metastasis requiring prompt medical intervention - Receipt of prior therapy with a TLR7/8/9 agonist and/or IFN-alpha - Prior chemotherapy, antibody, or other registered or experimental cancer treatment within 3 weeks of study Cycle 1 Day 1. Specifically, no CPI antibody is allowed to be 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, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment - Local therapy to liver (e.g. radiofrequency ablation, percutaneuous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, and transarterial embolization) within 3 weeks prior to initiation of study treatment, radioembolization within 3 months prior to initiation 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 2 toxicities: 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 situ not 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 to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome or Guillain-Barré syndrome - Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection. - Ascites, pleural effusion, or pericardial effusion requiring medical intervention within 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


Intervention

Drug:
RO7119929
RO7119929 will be administered orally as a capsule
Tocilizumab
Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome. Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants > 30 kg: 8 mg/kg, for participants < 30 kg: 12mg/kg IV

Locations

Country Name City State
Denmark Rigshospitalet; Onkologisk Klinik København Ø
Hong Kong Queen Mary Hospital; Dept of Medicine Hong Kong
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Spain Hospital Universitari Vall d'Hebron; Oncology Barcelona
Spain Clinica Universidad de Navarra Madrid; Servicio de Oncología Madrid
Spain Clínica Universidad de Navarra Pamplona Navarra
Taiwan Tri-Service General Hospital Taipei
Taiwan National Taiwan Uni Hospital Taipei City
United States City of Hope Cancer Center Duarte California

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Denmark,  Hong Kong,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nature and Frequency of Dose-Limiting Toxicities Baseline up to approximately 14 months
Primary Number of Participants with Adverse Events (AEs) According To NCI CTCAE v5.0 Baseline up to approximately 14 months
Secondary Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Secondary Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Secondary Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Secondary Half-Life (T1/2) for RO7119929 Following Administration of RO7119929 Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Secondary Objective Response Rate (ORR) according to RECIST v1.1 Baseline up to approximately 14 months
Secondary Disease Control Rate (DCR) according to RECIST v1.1 Baseline up to approximately 14 months
Secondary Progression-Free Survival (PFS) according to RECIST v1.1 Baseline up to approximately 14 months
Secondary Overall Survival (OS) Baseline up to approximately 14 months
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