Terminated • Phasen I • Stufe III, IV • ER negativ • PR negativ • HER2 negativ • Medical Oncology • Post-Menopausal • Interventionell

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A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Brief Summary

This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, if approved for that indication).

Beschreibung

Part A: Dose escalation of PY159 alone and in combination with pembrolizumab in a standard 3+3 design Part B: Dose expansion of one or more dose levels of PY159 administered alone and in combination with pembrolizumab for predefined tumor histology

Studiendesign

Zulassungskriterien

Arms and Intervention

• PY159 Single agent dose level 1

• PY159 Single agent dose level 2

• PY159 Single agent dose level 3

• PY159 Single agent dose level 4

• PY159 Single agent dose level 5

• PY159 Single agent dose level 6

• PY159 Single agent dose level 7

• PY159/Pembrolizumab Combination dose level 1

• PY159/Pembrolizumab Combination dose level 2

• PY159/Pembrolizumab Combination dose level 3

• PY159/Pembrolizumab Combination dose level 4

• PY159 Single agent dose expansion cohort

• PY159/Pembrolizumab Combination dose expansion cohort 1

• PY159/Pembrolizumab Combination dose expansion cohort 2

• PY159/Pembrolizumab Combination dose expansion cohort 3

• PY159/Pembrolizumab Combination dose expansion cohort 4

• PY159/Pembrolizumab Combination dose expansion cohort 5

• PY159/Pembrolizumab Combination dose expansion cohort 6