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TPST-1120
A Study of TPST-1120 With Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic HCC Not Previously Treated With Systemic Therapy
Ensayo de Tempest Therapeutics, Inc. en Carcinoma hepatocelular (HCC).
- Fase
- Fase 3
- Estado
- Aún sin reclutar
- Participantes
- 740
- Fin del objetivo primario
- dic 2028
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2025.
Qué mide
Supervivencia global (OS) (The time from randomization to death from any cause up to 60 months.) (del registro, en inglés)
Qué se prueba
Se prueba TPST-1120 combinado con atezolizumab y bevacizumab, frente a atezolizumab y bevacizumab solos, en pacientes adultos con carcinoma hepatocelular no resecable o metastasico, para ver si ayuda a vivir mas tiempo.
Lo que dice el documentodetermine 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).
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe 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.
Más ensayos de TPST
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| TPST-1495 twice daily | Fase 1 | Completado | sep 2024 (real) |
| Part 1 TPST-1120 | Fase 1 | Completado | sep 2022 (real) |
Todos los de TPST, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06680258), actualizada en sep 2025.