At a glance
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A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)
In Brief
A Phase 2 clinical trial evaluating CyPep-1 and Pembrolizumab 25 MG/ML [KEYTRUDA®] for Advanced Head and Neck Squamous Cell Carcinoma and 2 related conditions. Completed, enrolled 6 participants across 25 sites in 5 countries.
Detailed Summary
This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.
Study Details
Timeline
Interventions
Intratumoral injection
IV infusion