Recruiting • Phase I • Stages III, IV • ER negative • PR negative • HER2 negative • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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).

Description

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

Study Design

Eligibility Criteria

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