Status:
COMPLETED
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
Lead Sponsor:
Coherus Oncology, Inc.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 trial composed of an open label Lead-In followed by a Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compar...
Detailed Description
This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevac...
Eligibility Criteria
Inclusion
- Abbreviated
- ≥ 18 years of age on day of signing informed consent
- Unresectable locally advanced or metastatic HCC
- No prior systemic treatment for unresectable locally advanced or metastatic HCC
- BCLC Stage B or Stage C disease
- Child-Pugh Class A disease
- ≥ 1 measurable lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Laboratory values indicative of adequate organ function as defined in the protocol
- Women of childbearing potential must have a negative pregnancy test within 1 week prior to first dose of study drug
- Women of childbearing potential or men with a heterosexual partner of childbearing potential or pregnant must agree to refrain from sexual intercourse or be willing to use effective methods of contraception as defined in the protocol while receiving study drug and for 6 months after the last dose of any study drug
- Abbreviated
Exclusion
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Previously received an anti-interleukin (IL)-27 antibody (Ab) or anti-IL-27-targeted therapy.
- Received prior systemic therapy for unresectable or metastatic disease. (Note: Prior systemic therapies administered for neoadjuvant, adjuvant, or curative intent (localized disease) are permitted if they were given \> 1 year prior to the development of recurrent or metastatic disease)
- Known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Moderate or severe ascites
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- History of or current hepatic encephalopathy
- Unable to undergo disease evaluation with a triphasic CT or MRI because of contrast allergy or other contraindication
- Untreated or incompletely treated varices with bleeding or high risk for bleeding.
- Symptomatic or untreated brain metastases or leptomeningeal carcinomatosis.
- Active or history of autoimmune disease or immune deficiency with some exceptions such as controlled thyroid disease, Type 1 diabetes, eczema and other minor skin disorders.
- Medical conditions requiring chronic steroid therapy (ie, \> 10 mg/day of prednisone or its equivalent) or anticipates the need for systemic immunosuppressive medications during treatment with study drug
- Known active infection with HIV
- Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), except for controlled active HBV or fully treated HCV infection as defined by the protocol
- Inadequately controlled arterial hypertension
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05359861
Start Date
April 12 2022
End Date
July 8 2025
Last Update
November 10 2025
Active Locations (37)
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1
University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
2
City of Hope
Duarte, California, United States, 91010
3
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610