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TPST-1120

Phase 3

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

Target and mechanism

Molecular targetPPARα
Target classNuclear Receptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment740

FDA Designations

No designations recorded

Clinical trial landscape

TPST-1120 · 1 trial · 1 indication

Phase 3 1
NCT06680258A Study of TPST-1120 With Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic HCC Not Previously Treated With Systemic TherapyHepatocellular Carcinoma (HCC)
NOT YET_RECRUITING740 Analytics
PHASE3NOT YET_RECRUITING
A Study of TPST-1120 With Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic HCC Not Previously Treated With Systemic Therapy
Hepatocellular Carcinoma (HCC)Unlock trial analytics

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 to 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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Frequently asked questions about TPST-1120

What is TPST-1120 used for in Hepatocellular Carcinoma?

TPST-1120 is an investigational small molecule being studied for the treatment of unresectable or metastatic Hepatocellular Carcinoma (HCC) in patients who have not previously received systemic therapy. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

What does TPST-1120 target?

TPST-1120 targets PPARα, a nuclear receptor involved in metabolic regulation. By modulating this target, the drug is being evaluated for its potential role in treating Hepatocellular Carcinoma. Its exact mechanism of action in this context is under investigation in clinical trials.

Who makes TPST-1120?

TPST-1120 is being developed by Tempest Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TPST. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Hepatocellular Carcinoma.

What phase is TPST-1120 in?

TPST-1120 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is designed to assess its efficacy and safety in patients with previously untreated unresectable or metastatic Hepatocellular Carcinoma.

What clinical trials is TPST-1120 in?

TPST-1120 is being studied in a Phase 3 clinical trial with the identifier NCT06680258. This randomized, double-blind, active-controlled study is evaluating TPST-1120 in combination with atezolizumab plus bevacizumab in patients with unresectable or metastatic Hepatocellular Carcinoma who have not received prior systemic therapy. The trial aims to enroll approximately 740 participants.