Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carc… (NCT05359861) | Clinical Trial Compass
CompletedPhase 2
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
United States30 participantsStarted 2022-04-12
Plain-language 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 compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Nature, frequency, and severity of adverse events (AEs) per NCI CTCAE version 5.0 or higher
Timeframe: Up to 2 years
2
Progression Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)