Atezolizumab + Bevacizumab +/− SRF388 for Liver Cancer

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Coherus Biosciences, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests SRF388 with atezolizumab and bevacizumab in patients with advanced liver cancer. The treatment aims to enhance immune response and block blood supply to tumors. Atezolizumab and bevacizumab have become the standard of care for advanced hepatocellular carcinoma, replacing sorafenib which was the standard for over ten years.

Research Team

Koho Iizuka, MD

Principal Investigator

Coherus Biosciences, Inc.

Eligibility Criteria

Adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic treatment for their condition can join this trial. They should be in relatively good health, able to perform daily activities with ease or slight difficulty, and have a liver that's still working well. Pregnant women can't participate, and those who can have children must use birth control.

Inclusion Criteria

My liver disease is mild.

I haven't had any treatments for my advanced liver cancer.

Laboratory values indicative of adequate organ function as defined in the protocol

Exclusion Criteria

I frequently need procedures to remove excess fluid from my body.

I am on or might need strong medication to suppress my immune system.

I have an autoimmune disease or immune deficiency, but it's controlled or minor.

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Bevacizumab (Monoclonal Antibodies)
• Placebo (Other)
• SRF388 (Monoclonal Antibodies)

Trial Overview The study is testing the effectiveness of SRF388 combined with Atezolizumab and Bevacizumab versus a placebo mixed with the same two drugs in treating first-line advanced liver cancer. Participants are randomly assigned to one of these groups to compare results.

Participant Groups

Group I: Lead-In Experimental Treatment 3 Interventions

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.

Group II: Arm B: Placebo in combination with atezolizumab plus bevacizumab Experimental Treatment 3 Interventions

Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.

Group III: Arm A: SRF388 in Combination with atezolizumab plus bevacizumab Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Coherus Biosciences, Inc.

Lead Sponsor

Trials

19

Recruited

3,700+

Surface Oncology

Lead Sponsor

Trials

6

Recruited

730+