About this trial
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.
Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of
Liver Diseases criteria in cirrhotic patients
Child-Pugh class A within 7 days prior to randomization
Disqualifiers
Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2a
Treatment with investigational therapy within 28 days prior to initiation of study
Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding
Trial design
Treatments tested in this trial
- Atezolizumab
- Bevacizumab 15 mg/kg
- Tiragolumab
- Tocilizumab
- TPST-1120
- Tobemstomig 2100 mg
- Bevacizumab 10 mg/kg
- Tobemstomig 600 mg
- Tobemstomig 1200 mg
- ADG126
- IO-108 1800 mg
- NKT2152
- IO-108 1200 mg
Treatment groups
11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Hoffmann-La Roche
Lead sponsor
Adagene Inc
Collaborator
Tempest Therapeutics
Collaborator
NiKang Therapeutics, Inc.
Collaborator
Immune-Onc Therapeutics
Collaborator