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TPST-1120

Phase 3

Hepatocellular Carcinoma (HCC) | Small molecule | Oncology |Tempest Therapeutics, Inc.|Last Updated: Sep 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment740
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06680258A Study of TPST-1120 With Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic HCC Not Previously Treated With Systemic TherapyPHASE3 NOT YET_RECRUITING 740Dec 1, 2025Jul 1, 2030Sep 3, 2025 -
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Study Endpoints
Primary Endpoints
Overall Survival (OS)
The time from randomization to death from any cause up to 60 months.

Overall survival (OS), defined as the time from randomization to death from any cause up to 60 months.

Secondary Endpoints
Progression free survival
The time from randomization to first occurence of disease progression or death from any cause (whichever occurs first) up to 60 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active ArmEXPERIMENTALTPST-1120 600 mg by mouth (PO) twice daily (BID) with atezolizumab 1200 mg intravenously (IV) every 3 weeks (Q3W) and bevacizumab 15 mg/kg IV Q3W
Control ArmACTIVE_COMPARATORPlacebo tablets PO BID with atezolizumab 1200 mg IV Q3W and bevacizumab 15 mg/kg IV Q3W
Interventions
NameTypeDescription
TPST-1120DRUGTPST-1120 is an orally administered competitive antagonist of peroxisome proliferator-activated receptor α (PPARα)
AtezolizumabBIOLOGICALAtezolizumab is an IV administered biologic.
BevacizumabBIOLOGICALBevacizumab is an IV administered biologic.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Written informed consent 2. Age ≥ 18 years at the time of signing ICF 3. HCC diagnosis confirmed by histology/cytology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients a) Patients without cirrhosis require hi...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06680258primaryCompletionDate: changed
LOWMay 24, 2026NCT06680258studyFirstPostDate: changed