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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Coherus Oncology, Inc.
Study ID
NCT05359861
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SRF388 — DRUG
    SRF388 will be administered by intravenous injection (IV)
  • Atezolizumab — DRUG
    Azezolizumab will be administered by IV
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV
  • Placebo — DRUG
    Placebo will be administered by IV

Study Details

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.

Key Dates

Start date
Apr 12, 2022
Status verified
Nov 2025
Primary completion
Jun 30, 2025
Completion
Jul 8, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lead-In
    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.
  • Experimental: Arm A: SRF388 in Combination with atezolizumab plus bevacizumab
    Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.
  • Experimental: Arm B: Placebo in combination with atezolizumab plus bevacizumab
    Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.

Primary Outcome Measure

Nature, frequency, and severity of adverse events (AEs) per NCI CTCAE version 5.0 or higher [ Time Frame: Up to 2 years ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - North CampusTucsonArizona85719-
City of HopeDuarteCalifornia91010-
University of Southern California - Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of Florida Health Science Center - GainesvilleGainesvilleFlorida32610-
University of Miami, Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Louisville VA Medical Center - Robley Rex VA Medical CenterLouisvilleKentucky40206-
University of Michigan Health System (UMHS)Ann ArborMichigan48109-
Veterans Affairs Ann Arbor Healthcare SystemAnn ArborMichigan48105-
Henry Ford HospitalDetroitMichigan48202-
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI))New YorkNew York10016-
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical CenterNew YorkNew York10010-
University of Oklahoma Health Sciences Center - Stephenson Cancer CenterOklahoma CityOklahoma73104-
Providence Portland Medical CenterPortlandOregon97213-
Sarah Cannon Research Institute - Tennessee OncologyChattanoogaTennessee37404-
Sarah Cannon Research Institute - Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Tucson, AZ

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Arizona Cancer Center - North Campus· Tucson, AZCity of Hope· Duarte, CAUniversity of Southern California - Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Florida Health Science Center - Gainesville· Gainesville, FLUniversity of Miami, Sylvester Comprehensive Cancer Center· Miami, FLLouisville VA Medical Center - Robley Rex VA Medical Center· Louisville, KY

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