Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.

Trial Details

NCT ID
NCT04787042
Phase
PHASE1 / PHASE2
Sponsor
Simcha IL-18, Inc.
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • ST-067
  • Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]
  • pembrolizumab
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Denver, Colorado, United States|39.73915,-104.9847
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Tampa, Florida, United States|27.94752,-82.45843
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Male and female patients aged ≥18 years
  • Must provide written informed consent and any authorizations required by local law
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor

For full eligibility, visit ClinicalTrials.gov.

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