Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 3:07 PM
Study NCT ID:
NCT06680258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TPST-1120 With Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic HCC Not Previously Treated With Systemic Therapy
Sponsor:
Tempest Therapeutics
Organization:
Study Overview
Official Title:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of TPST-1120 in Combination With Atezolizumab Plus Bevacizumab Compared With Placebo Plus Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Not Previously Treated With Systemic Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine if TPST-1120 in combination with atezolizumab and bevacizumab helps patients to live longer compared to atezolizumab and bevacizumab alone (the standard of care treatment) in adult patients with hepatocellular carcinoma that cannot be removed by surgery or has spread outside of the liver (called metastatic). The trial also will study the safety and side effects of the drug combination compared to the standard of care treatment. Other questions the trial aims to answer include:
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.
Detailed Description:
This is a Phase 3, randomized, multicenter, double-blind, Pbo-controlled study of TPST-AB versus Pbo-AB in patients with unresectable or metastatic HCC not previously treated with systemic therapy.
The study will consist of a screening period, a treatment period, and a follow-up period.
The purpose of this study is to measure the safety and efficacy of TPST-1120 in combination with atezolizumab plus bevacizumab compared with placebo plus atezolizumab plus bevacizumab in patients with unresectable or metastatic HCC who have received no prior systemic treatment. Study details include:
* Study duration: until death, loss to follow-up, withdrawal of consent, or study termination, whichever occurs first\]
* Treatment duration: until unacceptable toxicity or loss of clinical benefit
* Visit frequency: every 21 days
Approximately 740 patients are planned to be randomized and enrolled.
Eligible patients will be randomized in a 1:1 ratio to receive study intervention with the combination of TPST-AB or Pbo-AB as follows:
* Active arm: TPST-1120 600 mg per os (PO) twice daily (BID) with atezolizumab 1200 mg intravenously (IV) every 3 weeks (Q3W) and bevacizumab 15 mg/kg IV Q3W
* Control arm: Placebo PO BID with atezolizumab 1200 mg IV Q3W and bevacizumab 15 mg/kg IV Q3W
Patients may continue to receive study intervention until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status (e.g., symptomatic deterioration such as pain secondary to disease). In the absence of unacceptable toxicity, patients who meet criteria for disease progression per RECIST v1.1 while receiving study intervention will be permitted to continue the study intervention if they meet all of the following criteria:
* Evidence of clinical benefit, as determined by the investigator following a review of all available data
* Absence of symptoms and signs (including laboratory values, such as new or worsening hypercalcemia) indicating unequivocal progression of disease
* Absence of decline in Eastern Cooperative Oncology Group (ECOG) performance status that can be attributed to disease progression
* Absence of tumor progression at critical anatomical sites (e.g., leptomeningeal disease) that would require urgent alternative medical intervention
Patients will undergo tumor assessments at baseline and then, timed from initiation of treatment, every 9 weeks (± 1 week) for the first 54 weeks and then every 12 weeks (± 2 weeks) thereafter, regardless of study treatment holds or delays.
Patients who discontinue study intervention will return to the clinic for an End-of-Treatment (EOT) visit no more than 30 days after the final dose of study intervention and prior to the initiation of any new anti-cancer therapy/regimen.
After treatment discontinuation, information on survival follow-up and any new anti-cancer therapies started will be collected approximately every 3 months until death, withdrawal of consent or study completion.
The study will consist of a screening period, a treatment period, and a follow-up period.
The purpose of this study is to measure the safety and efficacy of TPST-1120 in combination with atezolizumab plus bevacizumab compared with placebo plus atezolizumab plus bevacizumab in patients with unresectable or metastatic HCC who have received no prior systemic treatment. Study details include:
* Study duration: until death, loss to follow-up, withdrawal of consent, or study termination, whichever occurs first\]
* Treatment duration: until unacceptable toxicity or loss of clinical benefit
* Visit frequency: every 21 days
Approximately 740 patients are planned to be randomized and enrolled.
Eligible patients will be randomized in a 1:1 ratio to receive study intervention with the combination of TPST-AB or Pbo-AB as follows:
* Active arm: TPST-1120 600 mg per os (PO) twice daily (BID) with atezolizumab 1200 mg intravenously (IV) every 3 weeks (Q3W) and bevacizumab 15 mg/kg IV Q3W
* Control arm: Placebo PO BID with atezolizumab 1200 mg IV Q3W and bevacizumab 15 mg/kg IV Q3W
Patients may continue to receive study intervention until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status (e.g., symptomatic deterioration such as pain secondary to disease). In the absence of unacceptable toxicity, patients who meet criteria for disease progression per RECIST v1.1 while receiving study intervention will be permitted to continue the study intervention if they meet all of the following criteria:
* Evidence of clinical benefit, as determined by the investigator following a review of all available data
* Absence of symptoms and signs (including laboratory values, such as new or worsening hypercalcemia) indicating unequivocal progression of disease
* Absence of decline in Eastern Cooperative Oncology Group (ECOG) performance status that can be attributed to disease progression
* Absence of tumor progression at critical anatomical sites (e.g., leptomeningeal disease) that would require urgent alternative medical intervention
Patients will undergo tumor assessments at baseline and then, timed from initiation of treatment, every 9 weeks (± 1 week) for the first 54 weeks and then every 12 weeks (± 2 weeks) thereafter, regardless of study treatment holds or delays.
Patients who discontinue study intervention will return to the clinic for an End-of-Treatment (EOT) visit no more than 30 days after the final dose of study intervention and prior to the initiation of any new anti-cancer therapy/regimen.
After treatment discontinuation, information on survival follow-up and any new anti-cancer therapies started will be collected approximately every 3 months until death, withdrawal of consent or study completion.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: