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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Cancer
• Solid Tumor
• Melanoma
• Renal Cell Carcinoma
• Triple-negative Breast Cancer
• Non Small Cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck
• Carcinoma
• MSI-High

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Simcha IL-18, Inc.

Last updated on ClinicalTrials.gov

November 15, 2024

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites