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SRF388

Phase 2

Hepatocellular Carcinoma | Small molecule | Oncology |Coherus Oncology, Inc.|Last Updated: Jun 29, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

SRF388 · 1 trial · 1 indication

Phase 2 1
NCT05359861Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular CarcinomaHepatocellular Carcinoma
COMPLETED30 Analytics
PHASE2COMPLETED
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Summaries of AEs will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study drug to 30 days after the last dose of study drug (Lead-In Phase).

Progression Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Up to 2 years

PFS according to RECIST v1.1 will be evaluated in patients receiving SRF388 in combination with atezolizumab plus bevacizumab compared to placebo in combination with atezolizumab plus bevacizumab (Randomized Phase).

Secondary Endpoints

Progression Free Survival (PFS) according to RECIST v1.1
Up to 2 years
PFS according to HCC modified RECIST (mRECIST)
Up to 2 years
Objective Response Rate (ORR) according to RECIST v1.1
Up to 2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lead-InEXPERIMENTALA 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.
Arm A: SRF388 in Combination with atezolizumab plus bevacizumabEXPERIMENTALPatients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.
Arm B: Placebo in combination with atezolizumab plus bevacizumabEXPERIMENTALPatients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.

Interventions

NameTypeDescription
SRF388DRUGSRF388 will be administered by intravenous injection (IV)
AtezolizumabDRUGAzezolizumab will be administered by IV
BevacizumabDRUGBevacizumab will be administered by IV
PlaceboDRUGPlacebo will be administered by IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

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 ...

Countries:United StatesAustraliaSouth KoreaTaiwan
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Recent Changes (Last 90 Days)

MEDIUMJul 30, 2026NCT05359861TRIAL_REMOVED: changed
MEDIUMJul 30, 2026NCT05359861TRIAL_REMOVED: changed
MEDIUMJul 30, 2026NCT05359861TRIAL_REMOVED: changed
MEDIUMJul 30, 2026NCT05359861TRIAL_REMOVED: changed

Frequently asked questions about SRF388

What is SRF388 used for in Hepatocellular Carcinoma?

SRF388 is an investigational small molecule being studied for the treatment of Hepatocellular Carcinoma. It is currently in Phase 2 clinical development. In a completed trial, SRF388 was evaluated in combination with atezolizumab and bevacizumab versus placebo in patients with hepatocellular carcinoma.

Who makes SRF388?

SRF388 is being developed by Coherus Oncology, Inc., a subsidiary of Coherus BioSciences, which trades under the ticker CHRS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hepatocellular carcinoma.

What phase is SRF388 in?

SRF388 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial testing SRF388 in combination with atezolizumab and bevacizumab for hepatocellular carcinoma has been completed.

What clinical trials is SRF388 in?

SRF388 has been studied in one clinical trial, identified as NCT05359861. This Phase 2 trial, titled 'Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma,' enrolled 30 participants and has been completed.

Is SRF388 the same as atezolizumab or bevacizumab?

No, SRF388 is a distinct investigational small molecule. In the clinical trial NCT05359861, SRF388 was tested in combination with atezolizumab and bevacizumab, which are established cancer therapies. SRF388 is not the same drug as either of these agents.