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.
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
History of another malignancy
Known symptomatic brain metastases requiring >10 mg/day of prednisolone or equivalent
Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular block type II, third degree AV
Any degree of respiratory compromise (from either malignant or non-malignant disease)
Simcha IL-18, Inc.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator