Essen Biotech Initiates Phase 1/2 Clinical Trial for Ovarian Cancer Treatment

Strategic Insights -

Essen Biotech has recently listed a Phase 1/2 clinical trial on ClinicalTrials.gov, aimed at evaluating the safety and efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer. The trial, which is currently recruiting 80 participants from the USA, will assess the safety, tolerability, and dose-limiting toxicities of the therapy. The Phase 1 portion will determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints such as objective response rate, progression-free survival, and overall survival.

Key Takeaways:

  • The trial is a multicenter, open-label Phase 1/2 clinical trial, evaluating the safety and preliminary efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer.
  • The trial will recruit 80 participants from the USA and will be conducted in a multicenter setting.
  • The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) to determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints including objective response rate, progression-free survival, and overall survival.
  • Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.
  • The trial is open for recruiting and can be viewed on ClinicalTrials.gov.

Statistics:

  • The trial will recruit 80 participants from the USA.
  • The trial is a multicenter, open-label Phase 1/2 clinical trial.
  • The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) for up to 1 month.
  • The Phase 2 portion will evaluate efficacy endpoints for up to 36 months.
  • Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.

Sources:

  • ClinicalTrials.gov (NCT07067255)
  • Contify.com (2017)