Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

Coherus Oncology, Inc.

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Placebo

Drug: Bevacizumab

Drug: Atezolizumab

Drug: SRF388

Study type

Interventional

Funder types

Industry

Identifiers

NCT05359861

SRF388-201

Details and patient eligibility

About

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 compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.

Full 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 bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC.

After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Abbreviated Inclusion Criteria:

≥ 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 Criteria:

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups

Lead-In

Experimental group

Description:

A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.

Treatment:

Drug: SRF388

Drug: Atezolizumab

Drug: Bevacizumab

Arm A: SRF388 in Combination with atezolizumab plus bevacizumab

Experimental group

Description:

Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.

Treatment:

Drug: SRF388

Drug: Atezolizumab

Drug: Bevacizumab