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Oncology Clinical Trial Finder

Breast Cancer
Location

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

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).

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

Breast Cancer

Study Design

Study type:

Interventional

Estimated enrollment:

343 participants

Actual study start date:

November 10, 2020

Eligibility Criteria

Ages eligible for study:

18 - 999

Sexes eligible for study:

both


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

Trial Information at Site

Last Updated:

Trial Information

ClinicalTrial.gov ID:

Recruiting

Estimated Enrollment:

343

Last Updated:

02/18/2023


Trial Contacts

Denise Deegan

ddeegan@pionyrtx.com

650-825-6140


Lynnae Jackson

ljackson@pionyrtx.com

805-750-0553


Principal Investigator

Len Reyno, MD


Trial Sponsor

Pionyr Immunotherapeutics Inc.

Study Locations (17)

Oregon Health and Science University

Portland, Oregon, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Colorado

Aurora, Colorado, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

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